Analysis of Data From the Women's Contraceptive and Reproductive Experiences (CARE) Study

December 14, 2019 updated by: National Human Genome Research Institute (NHGRI)

Genetic Analysis of Cancer Susceptibility Alleles in the CARE Case-Control Study

This study will continue to analyze data collected by the Women's Contraceptive and Reproductive Experiences (CARE) study. The CARE study was designed to evaluate the association between reproductive factors and risk of breast cancer in white and African-American women in the United States.

The present study is not recruiting additional participants. The original study enrolled 4,575 women with breast cancer and 4,682 control subjects between 35 and 64 years of age

All participants provided a blood sample for genetic study. The samples were analyzed for variants (mutations) in the BRCA1 and BRCA2 genes, the vitamin D receptor gene, the androgen receptor gene, and the insulin-like growth factor-1 gene.

In addition, all participants were interviewed to obtain information related to breast cancer risk, including a history of reproductive, menstrual, oral contraceptive, and hormone replacement therapy use; lifestyle factors such as smoking, alcohol use, body weight, and physical activity; history of medical conditions and procedures; demographic characteristics, such as age, race, marital status, and so forth; and a detailed family history of cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of the women's CARE study was a population based case control study designed to evaluate risk factors for breast cancer among white and African American women ages 35-64 in the United States. The study cases were U.S. born English-speaking women newly diagnosed with pathologically confirmed invasive breast cancer between July 1994 and April 1998. Cases were identified by the Surveillance, Epidemiology and End Results (SEER) cancer registry at each center except for Philadelphia where they were ascertained by field staff from local hospitals. African-American women were over sampled, as were younger case patients to maximize numbers in those strata. Older white case patients were randomly sampled to provide approximately equal numbers of patients in each 5-year age category. A total of 4575 cases were interviewed including 2953 white women and 1622 African American women.

Controls were U.S. born English-speaking women who had never been diagnosed with invasive or in situ breast cancer identified by random digit dialing. Controls were frequency-matched to cases by study center, race, and five-year age group. A total of 4682 controls were interviewed of which 3021 were white and 1661 were African American.

Information collected similarly from cases and controls focused on factors potentially related to the risk of breast cancer, including, reproductive, menstrual, oral contraceptive (OC) and Hormone Replacement Therapy (HRT) use histories; lifestyle factors such as smoking, alcohol use, body weight, and physical activity; selected history of medical conditions and procedures; demographic characteristics; and a detailed family history of cancer.

A total of 1652 Cases and 1453 controls provided high quality DNA in the form of blood samples. The Ostrander lab's role in the study was to screen the complete coding region, as well as intron-exon boundaries of 1652 cases and 600 controls for mutations in the BRCA1 and BRCA2 genes using both denaturing high performance liquid chromatograph (DHPLC) and direct sequencing. In addition we screened 1652 cases and 1453 controls for germline variants in the androgen receptor (AR), Insulin Like Growth Factor-1 (IGF-1) and vitamin D receptor (VDR) genes. The lab work for the study has been completed, and analysis is currently underway. This IRB file does not include a request to do any additional lab work. The focus of this request is to continue analysis of the now completed lab work in collaboration with the data-coordinating center at the Fred Hutchinson Cancer Research Center. Data coordination is lead by Drs. Kathleen Malone and Janet Daling of the Public Health Sciences Division of the FHCRC.

Study Type

Observational

Enrollment (Actual)

9257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Original recruitment were cases identified by the Surveillance, Epidemiology and End Results (SEER) cancer registry several years ago for the data set. Accrual is now completed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Elaine A Ostrander, Ph.D., National Human Genome Research Institute (NHGRI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 18, 2005

Study Completion

February 24, 2015

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

February 24, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999905089
  • 05-HG-N089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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