We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01197456
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : October 31, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Breast Cancer Ovarian Insufficiency Ovarian Failure

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
Study Start Date : September 2008
Primary Completion Date : June 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Exposed/chemotherapy
Breast cancer patients who will undergo chemotherapy
Unexposed
Breast cancer patients who will not undergo chemotherapy


Outcome Measures

Primary Outcome Measures :
  1. Ovarian insufficiency [ Time Frame: Years 1-5 ]
    Absence of menses for 12 months after breast cancer diagnosis


Secondary Outcome Measures :
  1. Return of menses [ Time Frame: Years 1-5 ]
    Return of menses after 12 months of amenorrhea


Biospecimen Retention:   Samples With DNA
Serum DNA

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197456


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of California, San Diego
University of Pennsylvania
University of Southern California
American Cancer Society, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Hui-Chun Irene Su, University of California, San Diego:
Breast cancer
Ovarian insufficiency
Ovarian failure
Reproduction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases