Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
- Conditions
- Breast CancerPrecancerous Condition
- Registration Number
- NCT00666731
- Lead Sponsor
- University of Nebraska
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4945
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Ongoing Web-based registry.
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers 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 Ongoing Web-based registries.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
Penrose Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Centura - Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Centura - St. Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Centura - Parker Adventist Hospital
🇺🇸Parker, Colorado, United States
Centura - St. Mary Corwin Medical Center
🇺🇸Pueblo, Colorado, United States
Halifax Health Medical Center
🇺🇸Ormond Beach, Florida, United States
Florida Hospital Memorial Medical Center
🇺🇸Daytona Beach, Florida, United States
Hlaifax Health Medical Center
🇺🇸Daytona Beach, Florida, United States
Florida Hospital Deland
🇺🇸DeLand, Florida, United States
Florida Hospital FISH
🇺🇸Orange City, Florida, United States
Scroll for more (54 remaining)Penrose Cancer Center🇺🇸Colorado Springs, Colorado, United States