Breast Cancer Clinical Trial
— POISEOfficial title:
Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
Verified date | April 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
More than two million American women are breast cancer survivors. Approximately one-third of
these women are premenopausal at diagnosis and face issues related to reproduction as they
undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on
breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire
for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian
function in breast cancer survivors could significantly impact physicians and patients in
counseling, medical and surgical treatment choices, and consideration of fertility
preservation options.
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.
Status | Completed |
Enrollment | 232 |
Est. completion date | July 18, 2019 |
Est. primary completion date | June 30, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - New diagnosis of breast cancer (Stages 0-III) - Age <=45 - Premenopausal (at least one menses over past year) - Has a uterus and at least one ovary Exclusion Criteria: - Prior chemotherapy |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | American Cancer Society, Inc., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania, University of Southern California |
United States,
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.00000000 — View Citation
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. — View Citation
Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimüllerian 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis | Number of participant without of menses for 12 months after breast cancer diagnosis | Years 1-5 | |
Secondary | Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea | Number of participants who experience return of menses after 3 months of amenorrhea | Years 1-5 |
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