Testicular Cancer

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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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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Condition: Ovarian Sex-cord Stromal Tumor, Testicular Stromal Tumors, Ovarian Small Cell Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT01970696

Sponsor: Children's Hospitals and Clinics of Minnesota

Phase:

Eligibility:

• Age: minimum 0 Years 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 (now enrolling these patients on PPB/DICER1 Registry), 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
• Adult Granulosa cell tumor (unless otherwise specified by Medical Director)

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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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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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Condition: Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02872532

Sponsor: Mayo Clinic

Eligibility:

• Age: minimum 0 Years 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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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

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

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

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