Biospecimen Analysis in Determining Effects of Chemothera... | NCT03206450

NCT03206450

Secondary IDs

ID	Type	Description	Link
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		View source
UG1CA189955	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biospecimen Collection	Procedure	Undergo collection of blood and provide saliva and semen samples	Observational (questionnaire, biospecimen collection)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infertility	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.	Up to 4 years
Follicle stimulating hormone levels	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.	Up to 4 years
Luteinizing hormone levels	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.	Up to 4 years
Testosterone levels	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.	Up to 4 years

Other Outcomes

Measure	Description	Time Frame
Role of genetic susceptibility in the development of impairments in spermatogenesis or steroidogenesis with contemporary regimens for the treatment of osteosarcoma	Analysis will be descriptive in nature and will be used to generate hypotheses for future studies.	Up to 4 years

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Margarett Shnorhavorian	Children's Oncology Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Alabama		Birmingham	Alabama	35233	United States
Phoenix Childrens Hospital

References Module

No data available