Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors
- Conditions
- Osteosarcoma
- Registration Number
- NCT03206450
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 224
Inclusion Criteria:<br><br> - Received upfront therapies for osteosarcoma, which included cisplatin, (with or<br> without other agents)<br><br> - Patient must have completed cancer treatment >= 2 years prior to study enrollment<br><br> - Osteosarcoma survivors without a systemically treated relapse or subsequent<br> malignancy<br><br> - Note: History of relapse or second malignancy is permitted if treated with<br> local therapy only (e.g. surgery, radiation)<br><br> - Able to speak, read and write in English, French or Spanish<br><br> - All patients and/or their parents or legal guardians must sign a written informed<br> consent<br><br> - All institutional, Food and Drug Administration (FDA), and National Cancer Institute<br> (NCI) requirements for human studies must be met
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infertility;Follicle stimulating hormone levels;Luteinizing hormone levels;Testosterone levels;Serum inhibin B;Sperm concentration;Sperm morphology;Sperm deoxyribonucleic acid methylation
- Secondary Outcome Measures
Name Time Method