Analysis of Data From the Women's Contraceptive and Reproductive Experiences (CARE) Study
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||April 19, 2017|
|Start Date ICMJE||January 18, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341159 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Analysis of Data From the Women's Contraceptive and Reproductive Experiences (CARE) Study|
|Official Title ICMJE||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.
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 ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Breast Cancer|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||9257|
|Estimated Completion Date||February 24, 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||35 Years to 64 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00341159|
|Other Study ID Numbers ICMJE||999905089
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Human Genome Research Institute (NHGRI)|
|Study Sponsor ICMJE||National Human Genome Research Institute (NHGRI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 24, 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP