Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors
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| ClinicalTrials.gov Identifier: NCT03206450 |
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Recruitment Status :
Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : May 26, 2023
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Osteosarcoma | Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 331 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma |
| Actual Study Start Date : | October 10, 2017 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Observational (questionnaire, biospecimen collection)
Participants complete a health questionnaire over 30-45 minutes. Patients also provide saliva and semen samples and undergo collection of blood.
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Procedure: Biospecimen Collection
Undergo collection of blood and provide saliva and semen samples
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies |
Primary Outcome Measures :
- Infertility [ Time Frame: Up to 4 years ]The American Society of Reproductive Medicine's definition of "infertility" as "… the failure to achieve a successful pregnancy after 12 months or more of regular unprotected intercourse" will be used to categorize patients as to a history of infertility. Based on interview questions regarding each subject's personal and partner's history of medical investigations and treatment for infertility, an attempt will be made to further distinguish each subject's history of infertility as being due to the male (study subject), the female or indeterminate. Will determine whether infertility differ in male osteosarcoma survivors treated with cisplatin with or without ifosfamide compared to male controls without a history of cancer. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Follicle stimulating hormone levels [ Time Frame: Up to 4 years ]Will be measured by immunofluorometric assay. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Luteinizing hormone levels [ Time Frame: Up to 4 years ]Will be measured by immunofluorometric assay. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Testosterone levels [ Time Frame: Up to 4 years ]Will be measured by radioimmunoassay. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Serum inhibin B [ Time Frame: Up to 4 years ]Will be measured by enzyme-linked immunosorbent assay. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Sperm concentration [ Time Frame: Up to 4 years ]Sperm concentration (per mL) will be assessed by Computer Assisted Sperm Analysis. Three separate counts will be performed and the results averaged. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Sperm morphology [ Time Frame: Up to 4 years ]Sperm morphology will be assessed. Will be analyzed using unconditional logistic regression models to estimate odds ratios and 95% confidence intervals for the associations of chemotherapy group with abnormal values as defined in clinical practice.
- Sperm deoxyribonucleic acid methylation [ Time Frame: Up to 4 years ]Genome-wide differentially methylated regions will be identified using methylated deoxyribonucleic acid immunoprecipitation followed by next generation sequencing analysis methylated deoxyribonucleic acid immunoprecipitation sequencing using pooled deoxyribonucleic acid. Sperm deoxyribonucleic acid differentially methylated regions will be confirmed in the pooled samples by bisulfite treatment of genomic deoxyribonucleic acid to convert cytosine to thymine followed by next generation sequencing for a bisulfite-sequencing analysis. Thus, methylated deoxyribonucleic acid immunoprecipitation- sequencing is used to identify the differentially methylated regions and bisulfite sequencing used to confirm the differentially methylated regions at the CpG level resolution. Pyrosequencing will be used involving next generation sequencing after polymerase chain reaction of individual sperm deoxyribonucleic acid samples to assess individual differentially methylated regions.
Other Outcome Measures:
- Role of genetic susceptibility in the development of impairments in spermatogenesis or steroidogenesis with contemporary regimens for the treatment of osteosarcoma [ Time Frame: Up to 4 years ]Analysis will be descriptive in nature and will be used to generate hypotheses for future studies.
Biospecimen Retention: Samples With DNA
saliva, semen, blood
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Osteosarcoma survivors who receive upfront therapies for osteosarcoma
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206450
Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Margarett Shnorhavorian | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT03206450 |
| Other Study ID Numbers: |
ALTE16C1 NCI-2017-01152 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ALTE16C1 ( Other Identifier: Children's Oncology Group ) COG-ALTE16C1 ( Other Identifier: DCP ) ALTE16C1 ( Other Identifier: CTEP ) R01CA175216 ( U.S. NIH Grant/Contract ) UG1CA189955 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 2, 2017 Key Record Dates |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | May 2023 |
Additional relevant MeSH terms:
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Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |