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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Assessment of the WATChmAN (Web virtuAl Testicular CANcer Clinic): A Randomized Controlled Study to Estimate the Efficacy of an Electronic Surveillance Tool for Stage I Testicular Cancer


Condition: Testicular Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03360994

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Men who are at least 18 years of age
  • Can read, write, and speak English
  • Have access to an electronic platform (i.e. computer, smart phone, tablet, etc.)
  • Have had histologically confirmed stage 1 testicular cancer (seminoma or non- seminoma),
  • Have undergone a radical orchiectomy in the last 9 months and will be/are on active surveillance under the supervision of the multidisciplinary testicular cancer clinic at Princess Margaret.
  • Must be prepared to comply with the close follow-up protocol and provide informed consent

Exclusion Criteria:

  • Men who have experienced metastatic disease or TCa relapse within their first 9 months of AS
  • Men with inadequate computer literacy or compliance as deemed by the study team

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Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study


Condition: Testicular Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03339635

Sponsor: University Medical Center Groningen

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 55 Years
  • Gender: Male

Inclusion Criteria:

  • patients with metastatic testicular cancer after unilateral orchidectomy and chemotherapy, at least 12 months after completion of last treatment and without evidence of disease. Combination chemotherapy should have contained a platinum compound, either cisplatin or carboplatin. In TC survivors, testosterone levels are routinely measured in blood during follow-up once every two years.
  • Patients are eligible for screening if they are between 18 and 55 years of age
  • have a documented low or low-normal total testosterone level ≤14 nmol/L, as measured during any of the follow-up visits, irrespective of signs and symptoms of androgen deficiency. Eligible for actual study participation and randomization between Androgel and placebo will be:
  • survivors of TC not using testosterone supplements, having biochemical evidence of hypogonadism (defined as a serum total testosterone concentration ≤ 12 nmol/L (345 ng/dL) measured after an overnight fast between 8:00 and 10:00 AM), and being overweight (as defined by a BMI ≥ 25 and <35 kg/m2).
  • Patients should be able to understand and abide to the study protocol and sign written informed consent.

Exclusion Criteria:

  • patients with a history of extragonadal testicular cancer
  • patients planning to father children within the next 12 months
  • patients taking corticosteroids or hormone replacement other than testosterone within 3 months of randomization
  • patients taking medication with any antiandrogenic effects (e.g. spironolactone)
  • patients with signs or history of hormone-dependent cancer (prostate or breast cancer)
  • patients with severe lower urinary tract symptoms (as defined by International Prostate Symptom Score >19)
  • patients with a history of coronary artery disease (angina pectoris, myocardial infarction) or heart failure
  • patients with hematocrit >50%
  • patients with untreated severe obstructive sleep apnea
  • patients with uncontrolled hypertension
  • patients with a BMI > 35 kg/m2
  • patients with a history of epilepsy
  • patients with debilitating psychiatric illness or inability to understand the study protocol, according to the opinion of the investigator

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Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma. A Multicenter, Open Label Phase II Trial With Two Cohorts


Condition: Seminoma, Testicular Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03937843

Sponsor: Swiss Group for Clinical Cancer Research

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Written informed consent according to ICH/GCP (International Council on Harmonization/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
  • Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
  • Patients with a seminoma stage IIA or IIB, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease. The tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 8th edition 2016. Patients with a recurrent seminoma stage IIA or IIB are only eligible in case of progression under active surveillance or recurrence after adjuvant carboplatin or radiotherapy for stage I disease
  • Stage IIA, in patients with equivocal lymph node enlargement, needs to be confirmed with a repeated CT/MRI scan of the abdomen (suggested timeframe: 4 weeks after the previous scan) in order to rule out false positive lymph node enlargement. Patients with a prior malignancy treated with curative intention are eligible if all treatment of that malignancy was completed at least 5 years before registration and the patient has no evidence of disease at registration. Less than 5 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence. Patients with a germ cell neoplasia in situ (GCNIS) or contralateral localized treated seminoma are eligible
  • Diagnostic CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis within 28 days prior to registration, showing stage IIA/B disease. I.v. contrast medium has to be administered
  • Age ≥ 18 years
  • WHO performance status 0-2
  • Baseline PRO questionnaires have been completed
  • Adequate bone marrow function: neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100x 109/L
  • Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
  • Patient agrees to use highly effective contraception and not to donate sperm or to father a child during trial treatment and during 12 months thereafter. Patient has been proposed sperm conservation. Exclusion criteria
  • Any other histological component than seminoma
  • Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
  • Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
  • Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
  • Any serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator's judgment)
  • Any treatment in a clinical trial within 28 days prior to registration
  • Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
  • Known hypersensitivity to trial drugs or to any component of the trial drugs
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. Additional German specific

Exclusion Criteria:

  • Any other histological component than seminoma
  • Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
  • Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
  • Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
  • Any serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator's judgment)
  • Any treatment in a clinical trial within 28 days prior to registration
  • Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
  • Known hypersensitivity to trial drugs or to any component of the trial drugs
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. Additional German specific exclusion criteria
  • not to be considered for Swiss patients
  • Patient who is dependent on the sponsor or the investigators according to ICH/GCP E6(R2), guideline
  • Patient who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities according to § 40a (2) AMG.

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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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Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS


Condition: Testicular Neoplasms

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02229916

Sponsor: Dr. med. Christian Rothermundt

Phase:

Eligibility:

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

Inclusion Criteria:

  • Written informed consent.
  • Histologically proven seminomas or non-seminoma.
  • Seminoma: complete remission (CR) or lymph nodes (LN) < 3cm or PET negative partial remission (PR) or non-seminoma: CR.
  • Completion of treatment within the last 6 months.
  • Patient able and willing to attend for regular surveillance.

Exclusion Criteria:

  • Co-existent malignancy within 5 years.
  • Inability for any reason to comply with the trial investigations or follow-up schedules.

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Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors


Condition: Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00432094

Sponsor: Masonic Cancer Center, University of Minnesota

Phase: Phase 2

Eligibility:

  • Age: minimum 10 Years maximum 69 Years
  • Gender: All

Inclusion Criteria:

  • Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2 as defined by the International Germ Cell Cancer Consensus Classification. Patients with increasing tumor markers only (i.e. no imaging evidence of progressive disease) are eligible for transplant.
  • Age: ≥ 10 years and < 70 years of age.
  • Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for subject 10
  • 15 years of age
  • Life expectancy: Greater than 8 weeks.
  • Patients must have normal organ function as defined below:
  • Hematologic:
  • Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days or Aranesp for 21 days
  • White blood cells (WBC) > 2.5 x 10^9/L with an absolute neutrophile count (ANC) > 1.5 x 10^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
  • Platelets > 100 x 10^9/L without transfusion and/or a bone marrow cellularity of ≥ 20%
  • Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min.
  • Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper limit of normal. No history of severe prior or ongoing chronic liver disease.
  • Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. LVEF ≥45% by MUGA/ECHO.
  • Pulmonary: Patients must have no significant obstructive airways disease (FEV1 must be ≥ 50% of predicted) and must have acceptable diffusion capacity (corrected DLCO > 50% of predicted).
  • Patients with a history of CNS tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment.

Exclusion Criteria:

  • Patients with serious uncontrolled infections will not be eligible.
  • Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation. The drugs used in this study are pregnancy category D
  • clear evidence of risk in pregnancy.
  • Pregnant and breast feeding women will not be eligible. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Additional Eligibility prior to Transplant Two:
  • Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one
  • Transplant able to occur between day +30 and day +90 from transplant one
  • Recovery of blood counts as demonstrated by:
  • WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
  • Platelets > 50 x 10^9/L without transfusion in the prior 7 days
  • Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min
  • Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper limit of normal
  • Infection: Patients with serious uncontrolled infections at the time of planned transplant will be excluded
  • Patients with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria by imaging techniques are not eligible to proceed to the second transplant. Tumor marker increase alone is not sufficient to diagnose disease progression.

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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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