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

September 8, 2010
June 20, 2014
September 2008
August 2015   (final data collection date for primary outcome measure)
Ovarian insufficiency [ Time Frame: Years 1-5 ] [ Designated as safety issue: No ]
Absence of menses for 12 months after breast cancer diagnosis
Same as current
Complete list of historical versions of study NCT01197456 on ClinicalTrials.gov Archive Site
Return of menses [ Time Frame: Years 1-5 ] [ Designated as safety issue: No ]
Return of menses after 12 months of amenorrhea
Same as current
Not Provided
Not Provided
 
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum DNA

Non-Probability Sample

Newly diagnosed breast cancer patients

  • Breast Cancer
  • Ovarian Insufficiency
  • Ovarian Failure
Not Provided
  • Exposed/chemotherapy
    Breast cancer patients who will undergo chemotherapy
  • Unexposed
    Breast cancer patients who will not undergo chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
August 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
United States
 
NCT01197456
UCSD POISE, K23HD058799, 5K23HD58799
No
Hui-Chun Irene Su, University of California, San Diego
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)
Not Provided
University of California, San Diego
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP