NCT00341159

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2015

Completed
Last Updated

December 17, 2019

Status Verified

February 24, 2015

First QC Date

June 19, 2006

Last Update Submit

December 14, 2019

Conditions

Keywords

BreastBRCA1BRCA2InheritedAssociationBreast CancerPopulation-BasedCancer Susceptibility Alleles

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Hall JM, Lee MK, Newman B, Morrow JE, Anderson LA, Huey B, King MC. Linkage of early-onset familial breast cancer to chromosome 17q21. Science. 1990 Dec 21;250(4988):1684-9. doi: 10.1126/science.2270482.

    PMID: 2270482BACKGROUND
  • Narod SA, Feunteun J, Lynch HT, Watson P, Conway T, Lynch J, Lenoir GM. Familial breast-ovarian cancer locus on chromosome 17q12-q23. Lancet. 1991 Jul 13;338(8759):82-3. doi: 10.1016/0140-6736(91)90076-2.

    PMID: 1676470BACKGROUND
  • Wooster R, Neuhausen SL, Mangion J, Quirk Y, Ford D, Collins N, Nguyen K, Seal S, Tran T, Averill D, et al. Localization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12-13. Science. 1994 Sep 30;265(5181):2088-90. doi: 10.1126/science.8091231.

    PMID: 8091231BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elaine A Ostrander, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 18, 2005

Study Completion

February 24, 2015

Last Updated

December 17, 2019

Record last verified: 2015-02-24

Locations