Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
NCT ID: NCT01197456
Last Updated: 2020-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
232 participants
OBSERVATIONAL
2008-09-24
2019-07-18
Brief Summary
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The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposed/chemotherapy
Breast cancer patients who will undergo chemotherapy
No interventions assigned to this group
Unexposed
Breast cancer patients who will not undergo chemotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \<=45
* Premenopausal (at least one menses over past year)
* Has a uterus and at least one ovary
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
University of Southern California
OTHER
American Cancer Society, Inc.
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, San Diego
OTHER
Responsible Party
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Hui-Chun Irene Su
Professor of Obstetrics, Gynecology, and Reproductive Sciences
Locations
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University of California, San Diego
La Jolla, California, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Su HC, Haunschild C, Chung K, Komrokian S, Boles S, Sammel MD, DeMichele A. Prechemotherapy antimullerian hormone, age, and body size predict timing of return of ovarian function in young breast cancer patients. Cancer. 2014 Dec 1;120(23):3691-8. doi: 10.1002/cncr.28942. Epub 2014 Jul 31.
Homer MV, Charo LM, Natarajan L, Haunschild C, Chung K, Mao JJ, DeMichele AM, Su HI. Genetic variants of age at menopause are not related to timing of ovarian failure in breast cancer survivors. Menopause. 2017 Jun;24(6):663-668. doi: 10.1097/GME.0000000000000817.
Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimullerian hormone levels among commercially available immunoassays. Fertil Steril. 2014 Jun;101(6):1766-72.e1. doi: 10.1016/j.fertnstert.2014.02.046. Epub 2014 Apr 14.
Other Identifiers
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UCSD POISE
Identifier Type: -
Identifier Source: org_study_id
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