Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2345817 participants
OBSERVATIONAL
1994-01-31
2009-12-31
Brief Summary
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* Maintain the BCSC pooled database using secure methods that protect the confidentiality of women, radiologists, facilities, and BCSC registries;
* Encourage and facilitate sharing of BCSC research resources, and continue developing and implementing our communications plan to expand resource dissemination;
* Provide statistical and scientific expertise to researchers, distribute customized limited datasets, and analyze BCSC data;
* Develop and support a new web-based dynamic query tool and other electronic interfaces to efficiently share aggregated BCSC data with the public.
Detailed Description
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* Carolina Mammography Registry in North Carolina (CMR)
* Group Health Registry in Seattle, Washington (GHC)
* New Hampshire Mammography Network (NHMN)
* San Francisco Mammography Registry (SFMR)
* Vermont Breast Cancer Surveillance System (VBCSS)
* New Mexico Mammography Project in Albuquerque (NMMP)
* Colorado Mammography Advocacy Project (CMAP)
These registries have been actively collecting data since 1994 or 1996 (depending on registry) including patient risk factors, clinical history, breast-imaging procedures (screening and diagnostic), benign and malignant pathology results, cancer outcomes, vital status, radiologist characteristics, and facility information. Some registries have data going back to the 1970s; however, this information is mostly used to determine prior breast cancer diagnoses and mammography exposure. Most analysis limit data to 1994 forward.
Registry procedures:
BCSC data will be shared using 4 main approaches:
1. Completed deidentified datasets and summary statistics made publicly available on the internet.
2. A web-based data query tool for automatically creating user-specified completely deidentified data sets and summary statistics.
3. Customized data sets created by the Statistical Coordinating Center (SCC) and delivered to investigators using secure methods, after BCSC steering committee approval of a research proposal.
4. Statistical analyses performed by the SCC, after BCSC steering committee approval of a research proposal.
Quality factors:
The data used by the BCSC have been previously collected directly from each BCSC registry. The BCSC database has no personal identifiers such as names, phone numbers, addresses, or social security numbers and no one in the population will be contacted for additional data collection. The data set only contains HIPAA limited identifiers: dates, ages \>89, and ZIP codes.
It is possible that new data will be collected under this contract as determined by the BCSC Steering Committee. This could include corrections to the current data, updates to existing data elements (e.g., additional radiology data, updated cancer and vital status outcomes), or new data elements (i.e., information about advanced imaging modalities, cancer biomarkers). New data will not contain personal identifiers. Individual-level data will never be shared unless rigorously examined and approved by the Steering Committee (which will include the principal investigators from each BCSC site) and the appropriate IRB safeguards are in place.
Our major objective for this contract is to maintain the current high standards of the BCSC database with no interruption in service to the scientific community. We will continue to be a resource to the research community, providing scientific and statistical expertise and conducting high-quality statistical analyses to advance breast cancer research. We will expand outreach and dissemination, so that more investigators are aware of this valuable resource and use it for their research. Our second objective is to develop new electronic interfaces and publicly available datasets that meet the highest possible standards for caBIG® compatibility. This will facilitate efficient sharing of BCSC data and expand potential for collaboration, increasing its value to the broader research community. Our ultimate aim is to facilitate research that improves breast cancer screening and reduces cancer burden and mortality.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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all women
women receiving mammography at one of 6 mammography registries across the country.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
University of California, San Francisco
OTHER
University of Vermont
OTHER
University of New Mexico
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Rebecca Hubbard, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Group Health Cooperative
Seattle, Washington, United States
Countries
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References
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Ballard-Barbash R, Taplin SH, Yankaskas BC, Ernster VL, Rosenberg RD, Carney PA, Barlow WE, Geller BM, Kerlikowske K, Edwards BK, Lynch CF, Urban N, Chrvala CA, Key CR, Poplack SP, Worden JK, Kessler LG. Breast Cancer Surveillance Consortium: a national mammography screening and outcomes database. AJR Am J Roentgenol. 1997 Oct;169(4):1001-8. doi: 10.2214/ajr.169.4.9308451. No abstract available.
Other Identifiers
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BCSC
Identifier Type: -
Identifier Source: org_study_id