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Clinical Trials/NCT01197456
NCT01197456
Completed
Not Applicable

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

University of California, San Diego2 sites in 1 country232 target enrollmentSeptember 24, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of California, San Diego
Enrollment
232
Locations
2
Primary Endpoint
Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 24, 2008
End Date
July 18, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hui-Chun Irene Su

Professor of Obstetrics, Gynecology, and Reproductive Sciences

University of California, San Diego

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis

Time Frame: Years 1-5

Number of participant without of menses for 12 months after breast cancer diagnosis

Secondary Outcomes

  • Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea(Years 1-5)

Study Sites (2)

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