CI

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ClinicalIndex Comparison Record
N/ACompleted· 232 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01197456
NCT01197456N/ACompleted

Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)

University of California, San Diego·observational·Posted Sep 9, 2010·Updated Apr 22, 2020

In Brief

An observational study for Breast Cancer and 2 related conditions. Completed, enrolled 232 participants across 2 sites.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2010
Enrollment StartSep 24, 2008
Primary CompletionJun 30, 2016
Study CompletionJul 18, 2019
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 15.8 years ago