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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Testosterone, Cognition, Ageing, and Cancer - A Controlled, Prospective Study About the Association Between Testosterone and the Prevalence and Severity of Cancer Related Cognitive Impairment in Testicular and Prostate Cancer Patients.


Condition: Cancer-related Cognitive Impairment

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03452436

Sponsor: University of Aarhus

Phase:

Eligibility:

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

Inclusion Criteria:

  • Confirmed diagnosis of testicular cancer
  • Confirmed diagnosis of prostate cancer and prescription of medical castration and radiotherapy

Exclusion Criteria:

  • Previous cancer disease
  • Previous central nervous system disease
  • Brain metastases
  • Severe psychiatric disease (e.g., schizophrenia, major depressive disorder)
  • Insufficient Danish proficiency for neuropsychological testing

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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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A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy


Condition: Non-seminomatous Germ Cell Tumors, Metastasis

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02317393

Sponsor: Centre Francois Baclesse

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Man or woman aged 18 years or more
  • Patients with one or several ganglionic or visceral residual masses (> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;
  • Affiliate to a social security system;
  • Signed written Informed consent

Exclusion Criteria:

  • Patient deprived of liberty as a result of a justice or administrative decision
  • Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
  • Previous or concomitant other cancer in 5 years except basal cell carcinomas

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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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    Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)


    Condition: Testicular Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02572934

    Sponsor: University Medical Center Groningen

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 70 Years
    • Gender: Male

    Inclusion Criteria:

    1. Age <70 years at time of inclusion
    2. Signed informed consent
    3. CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
    4. CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
    5. CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
    6. RT-group: Patients treated with radiotherapy for TC stage I or II.
    7. SU-group: Patients treated with orchidectomy only for TC stage I.

    Exclusion Criteria:

    1. Mental disorder (no informed consent available).
    2. CT-group: Patients also treated with radiotherapy for TC.
    3. RT-group: Patients also treated with chemotherapy for TC.
    4. SU-group: Patients also treated with chemo- or radiotherapy for TC.
    5. CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.

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    A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis


    Condition: Germ Cell Tumour

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01782339

    Sponsor: Barts & The London NHS Trust

    Phase: Phase 2

    Eligibility:

    • Age: minimum 16 Years maximum 65 Years
    • Gender: All

    Inclusion Criteria:

    • Germ Cell Tumour (GCT)
    • Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on PET CT Scan prior to entering study)
    • Neutrophil count >1.0x109/l
    • Platelets >70x109/l
    • Haemoglobin >100g/l (may be transfused)
    • Glomerular filtration rate >40ml/min (determined by EDTA clearance or calculated creatinine clearance using the Cockcroft
    • Gault equation if unable to perform EDTA clearance)
    • Males and females aged 16-65 years a) Male patients must have IGCCCG2 prognostic score, low to very high
    • Patients must be sterile or agree to use adequate contraception during the period of therapy
    • ECOG Performance status 0-3
    • Able and willing to give written informed consent and comply with the protocol study procedures.

    Exclusion Criteria:

    • Other malignancy except basal cell carcinoma
    • Significant co-morbidity likely to make delivery of this treatment unsafe
    • Currently enrolled in any other investigational drug study
    • Previous chemotherapy with oxaliplatin, methotrexate or Actinomycin D
    • Patients who have peripheral neuropathy with functional impairment

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    A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors


    Condition: Non-seminomatous Germ-cell Tumors

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02115165

    Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Male patients aged 15 years or older
    • Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
    • Primary site located in either the testis, the retroperitoneum or the mediastinum
    • Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
    • In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
    • No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
    • Life expectancy >/= 3 months
    • Adequate hematologic function :
    • Hemoglobin >/= 10.0 g/dL
    • Absolute neutrophil count >/= 1.5 x 10 ^ 9/L,
    • Platelet count >/= 100 x 10 ^ 9/L,
    • Adequate organ function
    • Serum creatinine < 1.5 x ULN. If serum creatinine 1.0
    • 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) > 60 mL/min
    • AST/SGOT and ALT/SGPT
    • Bilirubin
    • Information delivered to patient and informed consent form signed by the patient or his legal representative
    • Patient affiliated to a social security system or beneficiary of the same

    Exclusion Criteria:

    • Patients receiving anti cancer therapy within 4 weeks prior to enrolment
    • Previous radiotherapy within 4 weeks prior to enrolment
    • Serious uncontrolled concurrent medical illness
    • History of severe hypersensitivity reaction (>/= grade 3) to polysorbate 80 containing drugs or to other taxanes
    • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments.
    • Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel.
    • Active Grade >/= 3 peripheral neuropathy
    • Patients who have had a major surgery within 4 last weeks prior enrolment
    • Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed

    View trial on ClinicalTrials.gov


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    Multidisciplinary Etiologic Study of Familial Testicular Cancer


    Condition: Testicular Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00034424

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum 12 Years maximum 100 Years
    • Gender: All

    Inclusion Criteria:

    • Study population: Patients must be members of families with familial TGCT as defined below. Definition of familial TGCT: The criterion establishing familial TGCT is the presence of: -at least two cases of documented GCT in blood relatives (at least one of which is testicular in origin), OR
    • a single family member with bilateral testicular cancer,
    • men with a history of TGCT who are one in a set of identical siblings will also be included in the study. Case definition: A case will be determined to have TGCT according to the following criteria:
    • Pathologic confirmation of a germ cell derived tumor arising in the testis. Extragonadal germ cell tumors will also be included.
    • Germ cell derived histologies including: seminoma, germinoma, embryonal carcinoma, endodermal sinus (yolk sac) tumor, gonadoblastoma, choriocarcinoma, teratoma, and mixed germ cell tumor.
    • A case will be determined to have TIN on the basis of pathologic confirmation of intratubular malignant germ cells (ITMGCs) as defined by Burke and Mostofi. Individuals from participating families who are eligible for this study include: i) all TGCT cases; ii) All GCT cases (including those of ovarian or extra-gonadal sites); iii) all first-degree relatives of each TGCT case; iv) the spouse(s) of every case if the spouse and case had children who are participating in the study; v) any blood relative not included in (ii
    • iii) above who genetically links two cases; and vi) any blood relative with cancer other than TGCT vii) family members as described in i)
    • v) above must be age 12 or greater in order to participate

    Exclusion Criteria:

    1. Families will be deemed ineligible for participation in this study if: There are not at least two proven cases of GCT in the family, one of which is testicular in origin, unless there is a family member with bilateral testicular cancer; Deceased TGCT cases lacking both archival sources of tissue for DNA extraction AND lacking surviving spouses and children who are willing to paricipate in the study (unavailability of such persons prohibits inferring the genotype of the deceased individual with TGCT). Critical informative family members are unwilling to participate (i.e., unwilling to provide written informed consent); Pregnant women are excluded from participating while pregnant.

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