Summary

for females ages 18-45 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Hui-Chun Irene Su

Description

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.

Official Title

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

Keywords

Breast Cancer Ovarian Insufficiency Ovarian Failure Reproduction Breast Neoplasms Exposed/chemotherapy Unexposed

Eligibility

You can join if…

Open to females ages 18-45

  • 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

You CAN'T join if...

  • Prior chemotherapy

Locations

  • University of California, San Diego
    La Jolla California 92093 United States
  • University of Pennsylvania
    Philadelphia Pennsylvania 19104 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT01197456
Lead Scientist
Hui-Chun Irene Su
Study Type
Observational
Last Updated
October 2016