Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer (BCCR)

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ClinicalTrials.gov Identifier: NCT00666731

Recruitment Status : Completed

First Posted : April 25, 2008

Last Update Posted : May 15, 2017

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Kenneth Cowan, MD, University of Nebraska

Study Description

Brief Summary:

RATIONALE: Gathering information about patients with breast cancer and their families may help the study of breast cancer in the future.

PURPOSE: This clinical trial is gathering information about patients with breast cancer and their families.

Condition or disease	Intervention/treatment
Breast Cancer Precancerous Condition	Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: Excess human biological tissue Procedure: quality-of-life assessment

Detailed Description:

OBJECTIVES:

To develop a web-based Breast Cancer Collaborative Registry (BCCR) as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected at the National Comprehensive Cancer Network (NCCN) centers for participants with a personal history of breast cancer and/or characteristics of hereditary breast cancer.
To merge the data already being collected on breast cancer patients under the Adult Oncology Data Collection Study and newly diagnosed breast cancer patients participating in the NCCN Data Coordinating study at UNMC/NMC.
To standardize clinical, environmental, socio-demographic, and family history data for breast cancer-related information to be collected and shared for research purposes by Eppley Breast Cancer Research Group breast cancer research collaborators.
To collect, validate, and disseminate the breast cancer-related data to establish a high-risk cohort for future research into the molecular and biological bases of breast cancer susceptibility and interventional trials.

OUTLINE: This is a multicenter study.

Study participants undergo data collection related to breast cancer studies at one of the National Comprehensive Cancer Network (NCCN) centers for inclusion in the Breast Cancer Collaborative Registry (BCCR). The BCCR is a comprehensive computerized database that serves as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected for breast cancer patients treated on UNMC protocols. Central features of the registry include standardized data-entry forms and a relational database that can be used as a resource for the study of the pathology, immunology, cytogenetics, molecular biology, epidemiology, clinical features, and outcome of patients with benign, pre-malignant, or malignant breast disease.

Study participants complete a self-administered electronic or paper-based survey and a medical history questionnaire at baseline to provide information on demographics (e.g., age and sex); personal and family medical history; treatment history; lifestyle, physical activity, and dietary habits; quality of life; environmental exposure history; and the family tree for inclusion in the registry. Participants also undergo telephone or in-person structured interviews conducted by study coordinators, genetic counselors, or the System Coordinator of the BCCR to provide additional information or clarification of the information provided in the questionnaires.

Study participants also undergo review of their medical records and pathology reports to obtain detailed medical and treatment-related information for inclusion in the registry. The information collected includes retrospective and prospective disease-specific data (e.g., diagnosis, grade/stage, and laboratory values) and longitudinal outcome data (e.g., response to treatment, toxicity, survival, relapse) derived during prospective clinical follow-up.

Study participants are followed periodically to update relevant health and family histories.

Study Design


Study Type :	Observational
Actual Enrollment :	4945 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)
Actual Study Start Date :	October 2006
Actual Primary Completion Date :	December 31, 2016
Actual Study Completion Date :	December 31, 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Genetic and Rare Diseases Information Center resources: Breast Cancer, Male

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Other: medical chart review
Demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history.
Other: questionnaire administration
Collection of personal information, medical history, diet and lifestyle habits, any past or current environmental exposures and to re-create a family tree for any cancers that have occurred in any family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, year of birth, age of death) will be recorded.
Other: study of socioeconomic and demographic variables
Repository
Procedure: Excess human biological tissue
Tissue procurement.
Procedure: quality-of-life assessment
Cancer care.

Outcome Measures

Primary Outcome Measures :

Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers [ Time Frame: Ongoing ]
Web-based registry
Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC [ Time Frame: Ongoing ]
Web-based registries.
Standardization of clinical, environmental, socio-demographic, and family history data collected for breast cancer-related research and shared by the Eppley Breast Cancer Research Group collaborators [ Time Frame: Ongoing ]
Web-based registry.

Biospecimen Retention: Samples With DNA

Tissue, blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	19 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult individuals (male and female) who have a personal diagnosis/history of breast cancer, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) (as stated in the NCCN Breast and/or Ovarian Genetic Assessment Guidelines v.1.2006 (Appendix A)
Adult individuals who have characteristics of hereditary breast cancer, as defined in the NCCN Breast and/or Ovarian Genetic Assessment Guidelines v.1.2006 (Appendix A) or who have a breast cancer risk of > 1.67% over 5 years as estimated by GAIL Model (Appendix C )
Age 19 or greater
Able to provide informed consent

Criteria

DISEASE CHARACTERISTICS:

Recruited by a participating physician and meets at least 1 of the following criteria:
- Current diagnosis or history of breast cancer, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) as defined in the National Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment Guidelines, v.1.2006
- Characteristics of hereditary breast cancer, as defined in the National Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment Guidelines, v.1.2006 (relatives have been diagnosed with breast and/or ovarian cancer) OR have a breast cancer risk of > 1.67% over 5 years as estimated by the GAIL Model
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666731

Show 65 Study Locations

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Kenneth H. Cowan, MD, PhD	University of Nebraska

More Information


Responsible Party:	Kenneth Cowan, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier:	NCT00666731 History of Changes
Other Study ID Numbers:	311-06 P30CA036727 ( U.S. NIH Grant/Contract ) UNMC-31106
First Posted:	April 25, 2008 Key Record Dates
Last Update Posted:	May 15, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Collaborating centers may ask other centers to participate in future studies. Only shared among centers belonging to the BCCR


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Kenneth Cowan, MD, University of Nebraska:


male breast cancer breast cancer ductal breast carcinoma in situ lobular breast carcinoma in situ atypical ductal breast hyperplasia

Additional relevant MeSH terms:


Breast Neoplasms Precancerous Conditions Neoplasms by Site	Neoplasms Breast Diseases Skin Diseases

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