Testicular Cancer

Condition: Testicular Cancer, Seminoma, Quality of Life, De-escalation, RPLND

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07498959

Sponsor: Sahlgrenska University Hospital

Eligibility:

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

Inclusion Criteria:

• Patients ≥18 years undergoing an open or minimally invasive primary retroperitoneal lymph node dissection (RPLND) due to seminoma stage II A/B (maximum 2 nodes, <30 mm in any dimension)
• Patients undergoing an open or minimally invasive primary RPLND due to a retroperitoneal relapse of seminoma (maximum 2 nodes, <30 mm in any dimension)
• Patients ≥18 years scheduled for 3-4 courses of chemotherapy due to a newly diagnosed good-prognosis metastatic germ cell tumor (nonseminoma or seminoma)

Exclusion Criteria:

• Previous chemotherapy (including adjuvant chemotherapy at diagnosis)
• Previous RPLND
• Practical considerations, such as not being able to read and sign informed consent or understand the questionnaires

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Condition: Adenocarcinoma of the Bladder, Squamous Cell Carcinoma of the Bladder, Testicular Germ Cell Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06041503

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 120 Years
• Gender: All

Inclusion Criteria:

• Participants must have histologically confirmed locally advanced or metastatic pure adenocarcinoma of the urinary tract, pure squamous cell carcinoma of the urinary tract, or treatment-refractory testicular germ cell tumors. Note: For the purposes of enrollment, the urinary tract is defined as the renal pelvis, ureter, bladder, and urethra.
• Participants must have measurable disease, per RECIST 1.1.
• Participants must have locally advanced or metastatic disease defined as new or progressive lesions on cross sectional imaging.
• Participants in Cohorts A1, B1, and C1 must have received prior anti-PD-1/PD-L1 therapy in any setting.
• Participants in Cohorts A2, B2, and C2 must be immune checkpoint inhibitor naive.
• Participants may be systemic treatment naive except for participants with testicular germ cell tumors, who must have received and be refractory to all standard options of curative-intent treatment.
• Age >= 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status <= 1 (Karnofsky >= 70%)
• Participants must have adequate organ and marrow function as defined below:
• Hemoglobin (Hgb) >= 9g/dL
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin <= 1.5 x upper limit of normal (ULN) (<= 3 x ULN in participants with known/suspected Gilbert's disease)
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) <= 2.5 x institutional ULN
• Creatinine clearance (CrCl) >= 30 mL/min/1.73m^2 as estimated per institution standards.
• Pre-study treatment tissue availability (sufficient tissue for 25 unstained slides) is mandatory for enrollment. If tissue is determined to be insufficient/unsuitable, a fresh biopsy prior to study therapy will be required.
• Human immunodeficiency virus (HIV) positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART) for at least 3 months, CD4 counts are > 200 cells/mm^3 and viral load (VL) is undetectable.
• Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate guidance. For previously treated participants or those with prior infection that has been cleared, prophylaxis is permitted, and hepatology consultation recommended.
• Hepatitis C virus (HCV) positive participants are eligible if participants are on active HCV therapy at study entry and on a stable dose of antivirals without documented clinically significant impaired liver function test or hematologic abnormalities and with planned monitoring and management according to appropriate labeling, or if they are post-treatment for HCV. Participants that are positive for hepatitis C must have a negative polymerase chain reaction (PCR).
• Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence prior to study entry, for the duration of study participation, and for at least 4 months after the last dose of study drug(s).
• Men able to father children must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after the last dose of the study drug(s). We also will recommend men with female partners of childbearing potential to ask female partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).
• Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 4 months after the last dose of the pembrolizumab and 3 weeks after the last dose of EV.
• Participants must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy) within the past 2 weeks prior to the first study drug administration. Note: FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) are allowed to be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the investigator prior to enrollment.
• Participants with prior treatment with EV or other MMAE-based ADCs.
• Participants with preexisting sensory or motor neuropathy Grade >= 2.
• History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to EV and/or pembrolizumab.
• Symptomatic or untreated central nervous system (CNS) metastases. Note: Participants with previously treated brain or CNS metastases are eligible if the participants have recovered from any acute effects of radiotherapy and not requiring steroids, and any whole brain radiation therapy or any stereotactic radiosurgery was completed at least 2 weeks prior to initiation of study therapy.
• Participants will be excluded if they have an active autoimmune disease that might deteriorate when receiving pembrolizumab except for:
• Diabetes type I, eczema, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment.
• Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg of prednisone or equivalent per day.
• Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation).
• Participants on systemic intravenous or oral corticosteroid therapy with the exception of physiologic doses of corticosteroids (<= the equivalent of prednisone 10 mg/day) or other immunosuppressive agents such as azathioprine or cyclosporin A are excluded on the basis of potential immune suppression. For these participants these excluded treatments must be discontinued at least 1 week prior to treatment initiation for recent short course use (<= 14 days) or discontinued at least 4 weeks prior to treatment initiation for long term use (> 14 days). In addition, the use of corticosteroids as premedication for contrast-enhanced studies is allowed prior to treatment initiation and on study.
• History of uncontrolled diabetes mellitus within 3 months before the first dose of EV. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) >= 8% or HbA1c between 7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• Active keratitis or corneal ulcerations.
• Participants who have received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID-19 vaccines are permitted.
• Pregnant women as evaluated by a positive serum or urine beta-human chorionic gonadotropin (Beta-hCG) test at screening.
• Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.
• Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel. Participants with a prior (within 2 years of study therapy initiation) or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be permitted to join the study.

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Condition: Metastatic Triple Negative Breast Cancer or Metastatic Testicular Cancer, or Stage II-IV Diffuse Large B Cell Lymphoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07258563

Sponsor: University Medical Center Groningen

Eligibility:

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

Inclusion Criteria:

• Age ≥18 and ≤70 years
• Indication to start chemotherapy for:
• Metastatic triple negative breast cancer
• Metastatic testicular cancer
• Stage II-IV diffuse large B cell lymphoma
• Chemotherapy scheduled to start in the next 6 weeks
• Consuming solid foods and drinks is possible
• ≤50% of recommended daily intake in kcal consists of oral nutritional supplements
• Oral mucositis grade ≤2 (Common Terminology Criteria for Adverse Events, version 5.0)
• Ability to comply with all protocol-required actions
• Written informed consent
• For the intervention phase only: subjective change in taste since start of chemotherapy

Exclusion Criteria:

• Pregnancy
• Currently experiencing taste or smell problems
• Previous or current radiotherapy of head and neck region
• Enteral feeding through tube or parenteral feeding
• Participation in another clinical trial aimed at preventing or treating taste and/or smell alterations
• Chronic (>1 month) high dose corticosteroids (>10 mg prednisone/day or equivalent).

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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: 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 50 Years
• Gender: All

Inclusion Criteria:

1. Age ≥ 11 years and ≤ 50 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 hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour 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). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 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 hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour 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). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 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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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

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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