Trials / Completed
CompletedNCT03206450
Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors
Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 224 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This research trial studies saliva, semen, and blood samples to determine effects of chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes fertility problems and to learn more about the long term effects.
Detailed description
PRIMARY OBJECTIVES: I. Determine whether infertility and/or biomarkers of spermatogenesis and steroidogenesis differ in male osteosarcoma survivors treated with cisplatin with or without ifosfamide compared to male controls without a history of cancer. II. Evaluate whether cisplatin with or without ifosfamide for the treatment of osteosarcoma alters sperm deoxyribonucleic acid (DNA) methylation. EXPLORATORY OBJECTIVES: I. Evaluate the role of genetic susceptibility in the development of impairments in spermatogenesis or steroidogenesis with contemporary regimens for the treatment of osteosarcoma. OUTLINE: Participants complete a health questionnaire over 30-45 minutes. Patients also provide saliva and semen samples and undergo collection of blood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo collection of blood and provide saliva and semen samples |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2017-12-06
- Primary completion
- 2023-06-30
- Completion
- 2024-06-30
- First posted
- 2017-07-02
- Last updated
- 2024-08-26
Locations
99 sites across 3 countries: United States, Canada, Puerto Rico
Source: ClinicalTrials.gov record NCT03206450. Inclusion in this directory is not an endorsement.