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