Testicular Cancer

Condition: Cisplatin-induced Hearing Loss

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06521190

Sponsor: Acousia Therapeutics GmbH

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 45 Years
• Gender: Male

Inclusion Criteria:

• Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing chemotherapeutic regimen according to current treatment guidelines and site-specific tumor board recommendations
• Male adult patients at an age between 18 and 45 years
• Planned cis-Pt treatment with a cumulative dose of ≥300 mg/m2 which has to be administered in three chemotherapeutic cycles
• Normal or not clinically relevant otoscopic findings in both ears
• Normal hearing at both ears according to current WHO criteria for air-conduction 4PTA (0.5/1/2/4 kHz; 0 to 19 dB HL; average of audiometric thresholds at 0.5/1/2/4 kHz) at baseline
• Normal hearing at both ears according to ASHA criteria with a hearing threshold at any frequency (0.25 to 12 kHz) not exceeding 20 dB and a 4PTA (0.5/1/2/4 kHz) showing ≤15 dB HL at baseline
• Normal distortion product oto-acoustic emissions (DPOAE) present in both ears at baseline
• Patient shows normal results at trial start (V1) concerning heart rate (50 to 90 bpm), blood pressure (according to commonly accepted ranges), ECG (no pathological findings), and laboratory parameters (ie, liver and renal function values not clinically significant)
• Male patients and their female partner(s) must agree to use 2 forms of contraception (one of which must be a barrier method) during 6 months after trial start (V1)
• Patient is cooperative, able to understand all aspects of the trial, and able to speak German comparable to native speakers as per the investigator's discretion
• Patient has signed an approved informed consent form indicating that he understands the purpose of and procedures required for the trial, will follow the trial-specific measures, and is willing to participate in the trial

Exclusion Criteria:

• Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to KCNQ4)
• History of middle ear pathology or surgery, otitis externa, chronic otitis media, or recent acute otitis media (within ≤3 months)
• History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)
• Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane
• Hearing loss of >45 dB averaged at 6 and 8 kHz in either ear
• Sudden hearing loss or conductive hearing loss >10 dB at two frequencies in either ear
• Asymmetry in hearing thresholds between left and right ear ≥20 dB at any single frequency or ≥10 dB at any 3 consecutive frequencies ≤ 8 kHz
• Intake of any ototoxic drugs other than the intended cis-Pt-containing chemotherapeutic drug regimen prior to start of the trial and during the trial period
• Previous radiation exposure >35 Gray to complete or parts of the cochlea
• Severe concomitant diseases such as heart failure (NYHA II-IV), COPD, bronchial asthma, ongoing malignancies other than testicular cancer, auto-immune or chronic-inflammatory diseases, endocrinological diseases, advanced hepatic or renal failure, and primary complaint of tinnitus
• Planned consumption of medications, herbal preparations, and specific food ingredients to treat hearing problems and/or tinnitus during the trial period
• Hypersensitivity against any primary or secondary ingredient of IMP/Placebo medication
• Male patients with female partners who are pregnant or planning to become pregnant during 6 months after trial start (V1)
• Use of any other investigational medicinal product (IMP) within five times the half-life of that IMP/relevant metabolites or one month (whichever is longer) prior to screening and planned use during the trial or up to 30 days after trial completion
• Patient has any dependent relationship or employment status with respect to the trial site, the sponsor, the investigator, or any supervisor

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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: 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, Cancer-Related Condition, Infertility

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.)
• Be male 0-17 years of age
• Meet at least one of the following four conditions:
• 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 (Green et al., 2009) or 3. The Cyclophosphamide Equivalent Dose method (Green et al., 2014). Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators.
• High Risk
• >= 80% risk of prolonged azoospermia, Fertile Hope Brochure
• Summed alkylating agent dose score >= 3
• Cyclophosphamide equivalent dose >= 7,500mg/m^2
• Intermediate risk (21-79% risk of prolonged azoospermia, Fertile Hope)
• Low Risk ( =< 20% risk of prolonged azoospermia, Fertile Hope)
• Eligibility is limited to patients in the High risk category and/or intermediate risk after discussion with pediatric oncology, fertility preservation team, and the patient/family
• Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles
• Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome)
• 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 previous received therapy that is viewed as likely to result in complete and permanent loss of testicular function
• Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. Or have 1 testicle but limited potential for future fertility due to underlying condition, malignancy, prior surgery or previous torsion and no other fertility preservation methods are available except for testicular tissue cryopreservation
• 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 United States (U.S.) Department of Health and Human Services
• 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 human immunodeficiency virus (HIV)
• Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/ American Heart Association [ACC/AHA] Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon
• Note: In cases of torsion of testicles or other medical conditions that result in impairment of testicular function, patients can be consented and included in the study, if during the testicular surgery the provider finds that the patient still has viable tissue that can be cryopreserved. Exclusion Criteria: (Any

Exclusion Criteria:

• (Any exclusion criteria will disqualify.)
• Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
• Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
• 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

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

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

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