Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341159
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Analysis of Data From the Womens Contraceptive and Reproductive Experiences CARE Study
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genetic Analysis of Cancer Susceptibility Alleles in the CARE Case-Control Study
Status:
COMPLETED
Status Verified Date:
2015-02-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will continue to analyze data collected by the Womens 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 4575 women with breast cancer and 4682 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 present study is not recruiting additional participants The original study enrolled 4575 women with breast cancer and 4682 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
Detailed Description:
The purpose of the womens 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 US 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 US 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 labs 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
Controls were US 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 labs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-HG-N089 | None | None | None |