Predictors of Ovarian Insufficiency in Young Breast Cancer Patients (POISE)
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Purpose
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.
| Condition |
|---|
|
Breast Cancer Ovarian Insufficiency Ovarian Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study) |
- Ovarian insufficiency [ Time Frame: Years 1-5 ] [ Designated as safety issue: No ]Absence of menses for 12 months after breast cancer diagnosis
- Return of menses [ Time Frame: Years 1-5 ] [ Designated as safety issue: No ]Return of menses after 12 months of amenorrhea
Biospecimen Retention: Samples With DNA
Serum DNA
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Exposed/chemotherapy
Breast cancer patients who will undergo chemotherapy
|
|
Unexposed
Breast cancer patients who will not undergo chemotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Newly diagnosed breast cancer patients
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
Contacts and Locations| United States, California | |
| University of California, San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Leslie Barbier 858-822-6790 poisestudy.ucsd@gmail.com | |
| Principal Investigator: H. Irene Su, MD MSCE | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Sara Komrokian, MS 215-615-6822 poisestudy@gmail.com | |
| Principal Investigator: Angela DeMichele, MD MSCE | |
More Information
No publications provided
| Responsible Party: | Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01197456 History of Changes |
| Other Study ID Numbers: | UCSD POISE, K23HD058799, 5K23HD58799 |
| Study First Received: | September 8, 2010 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Breast cancer Ovarian insufficiency Ovarian failure Reproduction |
Additional relevant MeSH terms:
|
Breast Neoplasms Menopause, Premature Primary Ovarian Insufficiency Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013