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

  • STATUS
    Recruiting
  • End date
    Oct 10, 2021
  • participants needed
    331
  • sponsor
    Children's Oncology Group
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Updated on 30 November 2020
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Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+70 other location
cancer
cancer chemotherapy

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.

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.

Details
Treatment laboratory biomarker analysis, questionnaire administration, biospecimen collection
Clinical Study IdentifierNCT03206450
SponsorChildren's Oncology Group
Last Modified on30 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 50 yrs?
Are you male?
Do you have any of these conditions: Sarcoma or Osteosarcoma or Sarcoma (Pediatric) or Soft Tissue Sarcoma or Cancer Survivor?
Do you have any of these conditions: bone sarcoma or Cancer Survivor or Osteosarcoma or Sarcoma or Sarcoma (Pediatric) or Soft Tissue Sarcoma?
Do you have any of these conditions: Osteosarcoma or Sarcoma or Cancer Survivor or Sarcoma (Pediatric) or Soft Tissue Sarcoma or bone sarcoma?
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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