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

Children's Oncology Group

Status

Completed

Conditions

Osteosarcoma

Treatments

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Procedure: Biospecimen Collection

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT03206450

COG-ALTE16C1 (Other Identifier)

UG1CA189955 (U.S. NIH Grant/Contract)

NCI-2017-01152 (Registry Identifier)

R01CA175216 (U.S. NIH Grant/Contract)

ALTE16C1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Received upfront therapies for osteosarcoma, which included cisplatin, (with or without other agents)
Patient must have completed cancer treatment >= 2 years prior to study enrollment
Osteosarcoma survivors without a systemically treated relapse or subsequent malignancy
- Note: History of relapse or second malignancy is permitted if treated with local therapy only (e.g. surgery, radiation)
Able to speak, read and write in English, French 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