Predictors of Ovarian Insufficiency in Young Breast Cancer Patients (POISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Diego
Sponsor:
Collaborators:
University of Pennsylvania
University of Southern California
American Cancer Society, Inc.
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01197456
First received: September 8, 2010
Last updated: June 20, 2014
Last verified: June 2014
  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)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Ovarian insufficiency [ Time Frame: Years 1-5 ] [ Designated as safety issue: No ]
    Absence of menses for 12 months after breast cancer diagnosis


Secondary Outcome Measures:
  • 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
Study Population

Newly diagnosed breast cancer patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197456

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         
Sponsors and Collaborators
University of California, San Diego
University of Pennsylvania
University of Southern California
American Cancer Society, Inc.
  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: June 20, 2014
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:
Primary Ovarian Insufficiency
Breast Neoplasms
Menopause, Premature
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 September 11, 2014