Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 50
Updated:2/24/2019
Start Date:October 10, 2017
End Date:September 5, 2021

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

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.

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.

SECONDARY 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.

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
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