Breast CancerNCT00341159
Analysis of Data From the Women's Contraceptive and Reproductive Experiences (CARE) Study
An observational study of Breast Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Breast Cancer
- How many people
- 9,257 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2005to 24 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast, BRCA1, BRCA2, Inherited, Association, Breast Cancer, Population-Based, Cancer Susceptibility Alleles
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start18 Jan 2005
- Study completion24 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 9,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elaine A Ostrander, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341159
- Sponsor's protocol ID
- 999905089
- Other IDs
- 05-HG-N089
- Status last verified
- 24 Feb 2015
- First submitted
- 19 Jun 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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.
PubMed 2270482Narod 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.
PubMed 1676470Wooster 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.
PubMed 8091231
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Cancer Susceptibility Alleles in the CARE Case-Control Study
- ClinicalTrials.gov ID
- NCT00341159
- Acronym / sponsor ID
- 999905089
- Conditions
- Breast Cancer
- Keywords
- Breast, BRCA1, BRCA2, Inherited, Association, Breast Cancer, Population-Based, Cancer Susceptibility Alleles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,257 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 18 Jan 2005
- Study completion
- 24 Feb 2015
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 2270482Hall 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.
- Background: PubMed 1676470Narod 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.
- Background: PubMed 8091231Wooster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine A Ostrander, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341159, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.