Testicular Cancer

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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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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 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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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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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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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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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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    Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens


    Condition: Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02872532

    Sponsor: Mayo Clinic

    Eligibility:

    • Age: minimum N/A maximum 17 Years
    • Gender: Male

    Inclusion Criteria:

    • (All inclusion criteria must be met.) 1. Be male 0-17 years of age. 2. Meet at least one of the following four conditions: a. Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Risk categories based on treatment regimens are indicated below. Investigators will utilize three sources to calculate risk: 1."Fertile Hope
    • Risks of Azoospermia" brochure that details typical agents and treatment regimens in each risk category, 2. the Summed Alkylating Agent dose score, or 3. the Cyclophosphamide Equivalent Dose method. Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators. i. High Risk (1. ≥80% risk of prolonged azoospermia, Fertile Hope Brochure; 2. Summed alkylating agent dose score ≥3; 3. Cyclophosphamide equivalent dose ≥7,500mg/m2). ii. Intermediate Risk (21-79% risk of prolonged azoospermia, Fertile Hope). iii. Low Risk (≤20% risk of prolonged azoospermia, Fertile Hope). iv. Eligibility is limited to patients in the High Risk category. b. Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles. c. Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome). d. Or, have a newly diagnosed or recurrent disease affecting fertility. Those who were not enrolled at the time of initial diagnosis (i.e. patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function. 3. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. 4. Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 5. Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and HIV. 6. Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon. Exclusion Criteria: (Any

    Exclusion Criteria:

    1. (Any exclusion criteria will disqualify.)
    2. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
    3. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
    4. Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.

    View trial on ClinicalTrials.gov


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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

    View trial on ClinicalTrials.gov


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    Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment


    Condition: Childhood Cancer, Fertility Disorders

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03180918

    Sponsor: Gumy-Pause Fabienne

    Eligibility:

    • Age: minimum 3 Months maximum 18 Years
    • Gender: Male

    Inclusion Criteria:

    • Prepubertal patients aged 3 months and older
    • Peri and pubertal patients after failure of sperm cryopreservation
    • Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
    • Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

    Exclusion Criteria:

    • Patients under the age of 3 months
    • Refusal of the patient and/or his parents
    • Treatments that are not highly gonadotoxic

    View trial on ClinicalTrials.gov


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    Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment


    Condition: Childhood Cancer, Fertility Disorders

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03180918

    Sponsor: Gumy-Pause Fabienne

    Eligibility:

    • Age: minimum 3 Months maximum 18 Years
    • Gender: Male

    Inclusion Criteria:

    • Prepubertal patients aged 3 months and older
    • Peri and pubertal patients after failure of sperm cryopreservation
    • Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
    • Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

    Exclusion Criteria:

    • Patients under the age of 3 months
    • Refusal of the patient and/or his parents
    • Treatments that are not highly gonadotoxic

    View trial on ClinicalTrials.gov


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    Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment


    Condition: Childhood Cancer, Fertility Disorders

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03180918

    Sponsor: Gumy-Pause Fabienne

    Eligibility:

    • Age: minimum 3 Months maximum 18 Years
    • Gender: Male

    Inclusion Criteria:

    • Prepubertal patients aged 3 months and older
    • Peri and pubertal patients after failure of sperm cryopreservation
    • Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
    • Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

    Exclusion Criteria:

    • Patients under the age of 3 months
    • Refusal of the patient and/or his parents
    • Treatments that are not highly gonadotoxic

    View trial on ClinicalTrials.gov


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    Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment


    Condition: Childhood Cancer, Fertility Disorders

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03180918

    Sponsor: Gumy-Pause Fabienne

    Eligibility:

    • Age: minimum 3 Months maximum 18 Years
    • Gender: Male

    Inclusion Criteria:

    • Prepubertal patients aged 3 months and older
    • Peri and pubertal patients after failure of sperm cryopreservation
    • Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
    • Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

    Exclusion Criteria:

    • Patients under the age of 3 months
    • Refusal of the patient and/or his parents
    • Treatments that are not highly gonadotoxic

    View trial on ClinicalTrials.gov


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