- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206450
Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors
Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Jim Pattison Children's Hospital
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San Juan, Puerto Rico, 00926
- University Pediatric Hospital
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San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, United States, 85719
- Banner University Medical Center - Tucson
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California
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Downey, California, United States, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Oakland, California, United States, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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Torrance, California, United States, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, United States, 32610
- University of Florida Health Science Center - Gainesville
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston
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Hawaii
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital-Chicago
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Iowa
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Des Moines, Iowa, United States, 50309
- Blank Children's Hospital
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, United States, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Grand Rapids, Michigan, United States, 49503
- Helen DeVos Children's Hospital at Spectrum Health
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospitals and Clinics
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, United States, 89502
- Renown Regional Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, United States, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
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Tennessee
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Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
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Memphis, Tennessee, United States, 38105
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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El Paso, Texas, United States, 79905
- El Paso Children's Hospital
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Methodist Children's Hospital of South Texas
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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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Correlative studies
Ancillary studies
Undergo collection of blood and provide saliva and semen samples
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Infertility
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Follicle stimulating hormone levels
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Luteinizing hormone levels
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Testosterone levels
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Serum inhibin B
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Sperm concentration
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Sperm morphology
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Sperm deoxyribonucleic acid methylation
Time Frame: Up to 4 years
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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.
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Up to 4 years
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Other Outcome Measures
Outcome Measure |
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
Time Frame: Up to 4 years
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Analysis will be descriptive in nature and will be used to generate hypotheses for future studies.
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Up to 4 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margarett Shnorhavorian, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTE16C1 (Other Identifier: CTEP)
- UG1CA189955 (U.S. NIH Grant/Contract)
- NCI-2017-01152 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-ALTE16C1 (Other Identifier: DCP)
- R01CA175216 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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