Testicular Cancer

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Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment


Condition: Testicular Germ Cell Tumor

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03980587

Sponsor: Royal Marsden NHS Foundation Trust

Phase:

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients with histologically confirmed metastatic GCT refractory/resistant to platinum treatment
  • Patients who have signed the 'Tissues for Research' consent form at the Royal Marsden Hospital and have blood samples stored in the RMH Biobank.
  • Patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or NCCN low risk prostate cancer (pT1 or pT2a Gleason ≤ 6, PSA ≤ 10 and ≤ 1cc total volume)

Exclusion Criteria:

  • n/a

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Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study


Condition: Testicular Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04113122

Sponsor: University Medical Center Groningen

Eligibility:

  • Age: minimum 18 Years maximum 50 Years
  • Gender: Male

Inclusion Criteria:

  • In order to be eligible to participate in the cross-sectional part of this study, a subject must meet all of the following criteria:
  • Diagnosed with metastatic testicular cancer in 1999-2012 (stage II or higher)
  • Received first-line cisplatin-based chemotherapy
  • Was younger than 50 years of age at start of chemotherapy In order to be eligible to participate in the longitudinal part of this study, a subject must meet all of the following criteria: Chemotherapy-group:
  • Diagnosis of metastatic testicular cancer (stage II or higher)
  • Is about to start with first-line cisplatin-based chemotherapy
  • Younger than 50 years of age at diagnosis of metastatic testicular cancer Stage I control-group:
  • Diagnosis of testicular cancer stage I disease
  • Younger than 50 years of age at diagnosis of testicular cancer

Exclusion Criteria:

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Not able to provide informed consent (in example in case of mental or psychiatric disability)

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A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study


Condition: Testis Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04150848

Sponsor: University of California, Irvine

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 39 Years
  • Gender: Male

Inclusion Criteria:

  • between the ages of 18 and 39 years at the time of consent
  • confirmed diagnosis of testis cancer (any stage)
  • completed chemotherapy for testis cancer within 2 years prior to consent
  • fluency in English (per self-report)
  • sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)

Exclusion Criteria:

  • lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
  • active suicide plan
  • disorder that compromises comprehension of assessments or informed consent information
  • self-reported medical condition or medication use known to confound measures of systemic inflammation
  • daily smoking

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Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy


Condition: Testicular Cancer, Colorectal Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04180033

Sponsor: The Netherlands Cancer Institute

Eligibility:

  • Age: minimum 35 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • Diagnosis of TC before age of 50 years
  • Treatment of primary TC consisting at least: three cycles of platinum-based chemotherapy consisting of cisplatin
  • At least 8 years after initial treatment
  • At least 35 years of age and not older than 70 75 years
  • Detection and potential treatment of advanced colorectal neoplasia is considered beneficial

Exclusion Criteria:

  • A history of a proctocolectomy
  • Colonoscopy surveillance for other indications (including hereditary CRC syndrome, familial CRC syndrome, inflammatory bowel disease, history of colorectal adenoma or CRC). Result of the prior colonoscopy will be put in the database and used for additional analyses
  • Having received a colonoscopy in the past three years
  • Currently receiving cytotoxic treatment or radiotherapy for malignant disease
  • Coagulopathy (prothrombin time <50% of control; partial tromboplastin time >50 seconds) or anticoagulants (fenprocoumon, acenocoumarol, platelet aggregation inhibitors or new oral anticoagulants) that cannot be stopped or safely bridged if necessary
  • Comorbidity leading to an impaired physical performance (World health organization (WHO) performance status 3-4) or mental retardation
  • Limited Dutch language skills
  • No informed consent

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The PIONEER Initiative: Precision Insights On N-of-1 Effectiveness Research. Tissue Ownership by the Individual With the Return of Actionable Information to the Individual Patient and Physician (Precision Oncology)


Condition: Cancer, All Types, Cancer of Liver, Cancer of Stomach, Cancer of Head and Neck, Cancer of Rectum, Cancer of Kidney, Cancer of Esophagus, Cancer of Colon, Cancer Skin, Cancer of Cervix, Cancer, Metastatic, Cancer of Larynx, Cancer of Neck, Cancer of Lung, Cancer of Brain and Nervous System, Cancer of Vulva, Disseminated, Cancer of Pancreas, Sarcoma, GIST, Small-cell Lung Cancer, Adenocarcinoma Lung, Cancer of Prostate, Cancer, Advanced, Adrenal Cancer, Testicular Cancer, Uterine Cancer, Bronchoalveolar Cell Lung Cancer, Cancer Unknown Primary, Glioblastoma Multiforme, Oligodendroglioma, Breast Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, Cholangiocarcinoma, Squamous Cell Carcinoma, Transitional Cell Carcinoma, Cancer, Other, Cancer, Anal, Melanoma, Cancer, Bile Duct, Cancer, Bladder, Cancer Cords Vocal, Cancers Cell Neuroendocrine, Cancer Differentiated Poorly, Cancer, Anaplastic Thyroid

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03896958

Sponsor: SpeciCare

Phase:

Eligibility:

  • Age: minimum 1 Month maximum 99 Years
  • Gender: All

Inclusion Criteria:

  • All patients diagnosed with cancer and all patients at risk of cancer

Exclusion Criteria:

  1. -Patients who decline definitive therapies Patients with comorbidities that prevent definitive therapies Patients on hospice

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Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment


Condition: Male Infertility, Cancer, Epigenetic Disorder

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04200118

Sponsor: IVI Barcelona

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 65 Years
  • Gender: Male

Inclusion Criteria:

  1. Patients with previous history of cancer Patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them. Patients treated with chemotherapy and/or radiotherapy Patients have finished their oncological treatment. Patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample.

Exclusion Criteria:

  1. Patients with only one sperm sample cryopreserved Patients that are not be able to obtain a fresh sample post treatment Patients with less than 3 million sperm per milliliter

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Follow-up of Fertility in Young Adults Who Did or Did Not Store Testicular Tissue Before Gonadotoxic Treatment for Fertility Preservation.


Condition: Childhood Cancer, Childhood Hematological Disease

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04202094

Sponsor: Universitair Ziekenhuis Brussel

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Young adults (≥18 years).
  • Diagnosis of cancer or hematological disorder during childhood (<18 years).
  • High-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) during childhood.
  • At least one year after the last received gonadotoxic treatment.
  • Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy.

Exclusion Criteria:

  • Prepubertal patients and adolescents (<18 years).

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Phase II Single-arm Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)


Condition: Stage II A/B Seminomatous Germ Cell Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02797626

Sponsor: Heinrich-Heine University, Duesseldorf

Phase: Phase 2

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Inclusion Criteria:

  • histologically confirmed seminomatous testicular germ cell tumor
  • inguinal, paraaortic or retroperitoneal lymph nodes classified as local or regional unilateral lymph node metastasis by contrast CT or MRI
  • maximum dimensions of lymph node metastasis: single mass of max. 5.0 cm in transverse CT diameter multiple metastases in a unilateral field with single max. diameter of 5.0 cm (UICC IIB) patients with serum tumour marker elevation at the time of CT staging are eligible if the elevated human chorionic gonadotropin (hCG) directly before RPLND does not exceed 5 IU/L
  • patients qualify for this trial with following scenarios 1. initial diagnosis of UICC clinical stage IIA/IIB disease 2. recurrence after surveillance for clinical stage I 3. recurrence after adjuvant treatment of clinical stage I seminoma with 1 x carboplatin AUC7
  • curative treatment is intended
  • patient´s age above 18 years
  • able to communicate well with the investigator, to understand and comply with the requirements of the study, to understand and sign the written informed consent.

Exclusion Criteria:

  • non-seminomatous germ cell tumors
  • germ cell tumor-related AFP elevation suspicious of non-seminoma
  • metastatic lymph node mass with greatest dimension >5 cm (CS IIC)
  • other metastasis (CS III)
  • patients with prior scrotal or retroperitoneal surgery due to other diseases than germ cell cancer
  • patient underwent chemotherapy other than adjuvant Carboplatin monotherapy
  • patient underwent radiotherapy of the retroperitoneum
  • patient in reduced general condition or with live threatening disease
  • patient has a psychiatric disease
  • patient does not have sufficient knowledge of German language

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Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell


Condition: Testicular Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02478502

Sponsor: University Hospital, Akershus

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male patients ≥ 18 years old
  • Histologically verified metastatic germ cell cancer (GCC) of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum
  • Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
  • Life expectancy ≥ 3 months
  • At baseline adequate function of liver, kidneys and bone marrow: ·Neutrophils ≥ 1.5 x 109/L·
  • Hemoglobin ≥ 9.0 g/dL
  • Platelets ≥ 100 x 109/L
  • Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Total Bilirubin ≤ 1.0 x ULN
  • Serum glutamate oxaloacetate transaminase (SGOT/AST) ≤ 1.5 x ULN
  • Serum glutamate pyruvate transaminase (SGPT/ALT) < 1.5 x ULN

Exclusion Criteria:

  • Systemic antitumor treatment within 21 days before study entry
  • Simultaneous radiotherapy to the only target lesion
  • Patients unwilling or unable to comply with the protocol
  • Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure New York Heart Association (NYHA) III-IV or serious uncontrolled cardiac arrhythmias
  • Patients with an active or uncontrolled infection
  • Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer
  • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
  • Patients who have participated in another interventional clinical trial within 30 days before study entry
  • Other serious medical conditions that could impair the ability of the patient to participate in the study
  • Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
  • Neuropathy ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)
  • Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel
  • One or more of the following cabazitaxel-specific requirements:
  • History of severe hypersensitivity reaction (≥ Grade 3) to docetaxel
  • History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4) (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
  • Concurrent or planned treatment with Organic anion transporting polypeptide1B1 (OATP1B1) substrates e.g. statins, valsartan, repaglinide which have to be taken within 12 hours before cabazitaxel application and 3 hours after the end of infusion, refer table 9

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Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours


Condition: Germ Cell Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02582697

Sponsor: University of Sydney

Phase: Phase 3

Eligibility:

  • Age: minimum 11 Years maximum 45 Years
  • Gender: All

Inclusion Criteria:

  1. Age ≥ 11 years and ≤ 45 years on the date of randomisation
  2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
  3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  4. Metastatic disease or non-testicular primary
  5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
  6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L
  7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN
  8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan
  9. ECOG Performance Status of 0, 1, 2, or 3
  10. Study treatment both planned and able to start within 14 days of randomisation.
  11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
  12. Able to provide signed, written informed consent Exclusion Criteria:
  13. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
  14. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
  15. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
  16. Significant co-morbid respiratory disease that contraindicates the use of bleomycin
  17. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
  18. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  19. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
  20. Known allergy or hypersensitivity to any of the study drugs
  21. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and

Exclusion Criteria:

  1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
  2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
  3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
  4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin
  5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
  6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
  8. Known allergy or hypersensitivity to any of the study drugs
  9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

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A Randomized Phase III Study Comparing One Course of Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) and One Course of Carboplatin AUC7 in Clinical Stage I Seminomatous Testicular Cancer


Condition: Testicular Neoplasms, Seminoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02341989

Sponsor: St. Olavs Hospital

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 60 Years
  • Gender: Male

Inclusion Criteria:

  • Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
  • Clinical stage I
  • Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
  • Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted.
  • Age ≥ 18 years and < 60 years
  • Adequate organ function defined as: Serum aspartate transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance > 50 ml/min (eGFR) All fertile patients should use safe contraception Written informed consent

Exclusion Criteria:

  • Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
  • Prior diagnosis of testicular cancer
  • Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
  • Cancer other than seminoma testicular cancer
  • Known hypersensitivity or contraindications for the study drugs
  • Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
  • Medical, social, psychological conditions that could prevent adequate information and follow-up

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Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors


Condition: Germ Cell Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02303015

Sponsor: Rigshospitalet, Denmark

Phase:

Eligibility:

  • Age: minimum 15 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Danish citizen
  • Diagnosed with germ cell cancer from 1984 to 2007
  • Treated initially at a Danish hospital
  • Treated with standard treatment regimens.

Exclusion Criteria:

  • Treated initially at a foreign hospital

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International Ovarian & Testicular Stromal Tumor Registry


Condition: Ovarian Stromal Tumor, Testicular Stromal Tumors, Ovarian Small Cell Carcinoma, DICER1 Gene Mutation

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT01970696

Sponsor: Children's Hospitals and Clinics of Minnesota

Phase:

Eligibility:

  • Age: minimum N/A maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • Previous or current diagnosis of an ovarian sex cord stromal including but not limited to: Sertoli-Leydig cell tumor, gynandroblastoma, juvenile granulosa cell tumor, Sertoli cell tumor, sex cord stromal tumor with annular tubules or undifferentiated stromal tumor
  • Previous or current diagnosis of a testicular stromal tumor including but not limited to: juvenile granulosa cell tumor, Sertoli cell tumor, Leydig cell tumor or undifferentiated stromal tumor

Exclusion Criteria:

  • Unable to provide informed consent/assent

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Germ Cell Tumor and Testicular Tumor DNA Registry


Condition: Germ Cell Tumor, Testicular Tumor

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02099734

Sponsor: Memorial Sloan Kettering Cancer Center

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Case Cohort
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must have a diagnosis or suspicion of germ cell tumor and/or a testicular mass Family Member Cohort
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must be a blood relative of the proband. Family members of probands are eligible. These individuals need not have a diagnosis of GCT-TT, as they will be used for segregation analysis of suspected variants found in the proband. Control Cohort
  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must not have a personal history of cancer, with the exception of non-melanoma skin cancer, AND
  • Must not have a family history of germ cell tumor or testicular tumor AND
  • Must not be a blood relative of controls enrolled in this study

Exclusion Criteria:

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    Vascular Fingerprint to Identify Patients at Risk for Arterial Cardiovascular Events Within the First Year After Start of Cisplatin-based Chemotherapy for Testicular Cancer: a Validation Study


    Condition: Testicular Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02573584

    Sponsor: University Medical Center Groningen

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 50 Years
    • Gender: Male

    Inclusion Criteria:

    1. Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based chemotherapy for metastatic TC
    2. Classified into IGCCCG good or intermediate prognosis group
    3. Younger than 50 years of age at start of chemotherapy
    4. Signed informed consent

    Exclusion Criteria:

    1. History of previous cardiovascular disease
    2. Retroperitoneal mass > 5 cm
    3. Indication for anticoagulant therapy at start of chemotherapy

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    A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors


    Condition: Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Mixed Germ Cell Tumor, Yolk Sac Tumor, Childhood Teratoma, Malignant Germ Cell Neoplasm, Extragonadal Seminoma, Non-seminomatous Germ Cell Tumor, Seminoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02375204

    Sponsor: Alliance for Clinical Trials in Oncology

    Phase: Phase 3

    Eligibility:

    • Age: minimum 14 Years maximum N/A
    • Gender: Male

    Eligibility Criteria:

    • (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy).
    • Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy.
    • No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue)
    • No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed.
    • No concurrent treatment with other cytotoxic drugs or targeted therapies.
    • No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy.
    • No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol.
    • Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet) 4. Age ≥ 14 years (≥ 18 years in Germany) 5. ECOG Performance Status 0 to 2 6. Male gender 7. Required Initial Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
    • Platelet Count ≥ 100,000/mm^3
    • Calculated creatinine clearance ≥ 50 mL/min
    • Bilirubin ≤ 2.0 x upper limits of normal (ULN)
    • AST/ALT ≤ 2.5 x upper limits of normal (ULN) 8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed. 9. Negative Serology (antibody test) for the following infectious diseases:
    • Human Immunodeficiency Virus (HIV) type 1 and 2
    • Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe)
    • Hepatitis B surface antigen
    • Hepatitis C antibody 10. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible. 11. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide. 12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.

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    A Single-arm, Phase II Study of Durvalumab (MEDI4736) and Tremelimumab for Relapsed/Refractory Germ Cell Tumors


    Condition: Germ Cell Tumor, Nonseminomatous Germ Cell Tumor, Seminoma, Germinomatous Germ Cell Tumor, Dysgerminoma, Pineal Germ Cell Tumor

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03158064

    Sponsor: Memorial Sloan Kettering Cancer Center

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Age ≥ 18 years at time of informed consent
    • Body weight > 30 kg
    • Histologically confirmed diagnosis of GCT (nonseminoma or seminoma in men; non-dysgerminomas, dysgerminomas, or germinomas in women or patients with pineal gland GCT) at MSKCC of any primary site (includes female GCT and intracranial GCT).
    • Evidence of measurable disease either by RECIST 1.1 or elevation of serum tumor markers (AFP > 15 ng/mL or HCG >2.2 mIU/ml).
    • Patients must have progressed after at least one prior systemic therapy for GCT and meet one of the following criteria: a. Patients with evidence of progressive or recurrent GCT after progression prior high dose chemotherapy (HDCT) treatment, defined as meeting at least on of the following criteria: i. Tumor biopsy of new or growing or unresectable lesions demonstrating viable GCT. In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for this study. ii. Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. iii. Development of new or enlarging lesions in the the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to rise. b. Patients deemed not to be a candidate for or benefit from potentially curative HDCT or other curative treatment options defined as follows: i. Patients with inadequate renal function for HDCT. ii. Patients who have had 3 or more lines of prior chemotherapy as this patient population has historically not benefitted from HDCT. iii. Patients with late relapse (relapse > 2 years after last therapy) as this patient population has historically not benefitted from HDCT. iv. Patient with inadequate stem cell collection to move forward with HDCT. v. Patients with significant medical or psychosocial comorbidities that are felt to be a contraindication to HDCT by the treating investigator. NOTE: There is no maximum number of prior treatments allowed "Progression" after prior therapy is defined as any one of the following: NOTE: Patients with clinically growing "teratoma" (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery. In patients with rising tumor markers as their only evidence of disease progression where AFP is <30 or HCG is <15, alternate causes of increased levels of these markers should be ruled out. (e.g., hypogonadism by testosterone suppression of LH, hepatitis, use of marijuana).
    • Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Adequate normal organ and marrow function as defined below:
    • Hemoglobin ≥ 9.0 g/dL
    • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (> 1000 per mm3)
    • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
    • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (≤ 3 x institutional ULN in patient's with Gilbert's syndrome)
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN
    • Calculated creatinine clearance >30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
    • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply.
    • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Women >/= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
    • A positive serum pregnancy test must be confirmed by a pelvic US since some NSGCT may secrete beta-hCG and cause a false positive pregnancy. A pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so.
    • Female patients of reproductive potential, defined as not surgical sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal (see above for definition) and non-sterilized males who are sexually active with a female partner of reproductive potential must be willing to adhere to the following restrictions:
    • Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. It is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period Not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice.
    • Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Not engaging in sexual activity is an acceptable practice. Male patients should refrain from sperm donation throughout this period. It is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period.
    • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

    Exclusion Criteria:

    • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    • Previous enrolment in the present study
    • Participation in another clinical study with an investigational product during the last 14 days
    • Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
    • Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA-4, including tremelimumab
    • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 14 days prior to the first dose of study drug
    • Major surgery within 28 days of starting study treatment. There is no minimum time requirement for minor procedures such as biopsy or vascular access placement.
    • Radiation within 14 days of starting study treatment
    • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    • Systemic corticosteroids at physiologic doses not to exceed10 mg/day of prednisone or its equivalent
    • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
    • Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., alopecia, hearing loss, peripheral neuropathy).
    • History of pulmonary fibrosis by imaging or biopsy (including secondary to bleomycin), pneumonitis (including drug induced) requiring steroids ≥ 3 weeks, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan with associated symptoms.
    • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc)). The following are exceptions to this criterion:
    • Patients with vitiligo or alopecia
    • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician
    • Patients with diverticulosis
    • Patients with celiac disease controlled by diet alone
    • History of primary immunodeficiency
    • History of allogeneic organ transplant
    • History of hypersensitivity to durvalumab, tremelimumab or any excipient
    • Uncontrolled intercurrent illness including, but not limited to, on-going or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
    • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    • Known history of previous clinical diagnosis of tuberculosis
    • History of leptomeningeal carcinomatosis
    • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab. Inactivated vaccines, such as the injectable influenza vaccine, are permitted.
    • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
    • Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score 6, and prostate-specific antigen (PSA) 10 mg/mL, etc).
    • Patients should agree to not donate blood while participating in this study or for at least 90 days following the last infusion of durvalumab or tremelimumab
    • Female patients who are pregnant or breastfeeding

    View trial on ClinicalTrials.gov


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