Summary

for males ages 18-50 (full criteria)
at Oakland, California and other locations
study started
estimated completion

Description

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.

Official Title

Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Details

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. 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.

Keywords

Cancer Survivor Osteosarcoma Biospecimen Collection Laboratory Biomarker Analysis

Eligibility

For males ages 18-50

Inclusion Criteria:

  • Living
  • Previously enrolled and randomized on AOST0331 or INT0133 (also known as CCG7921 and POG9351)
  • Osteosarcoma survivors without relapse or a subsequent malignancy other than skin cancer following initial treatment on AOST0331 or INT0133 (also known as CCG7921 and POG9351)
  • Able to speak, read and write in English or Spanish
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations

  • Children's Hospital and Research Center at Oakland accepting new patients
    Oakland California 94609-1809 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT03206450
Study Type
Observational
Last Updated