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OpenTrials
Completed

NCT Number: NCT01197456

Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea

    Time frame: Years 1-5

    Number of participants who experience return of menses after 3 months of amenorrhea

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • American Cancer Society, Inc.
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Pennsylvania
  • University of Southern California

Registry information

Official study title

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

Acronym: POISE

Important dates

Study start
2008
Primary completion
2016
Study completion
2019
First posted
Sep 9, 2010
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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