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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00666731 |
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 | Intervention |
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Breast Cancer Precancerous/Nonmalignant Condition |
Other: informational intervention Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables |
Study Type: | Observational |
Official Title: | Development and Implementation of The Breast Cancer Collaborative Registry (BCCR) |
Estimated Enrollment: | 78 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicente 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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Recruited by a participating physician and meets at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Nebraska | |
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Recruiting |
Grand Island, Nebraska, United States, 68803 | |
Contact: Mary Gulzow 308-398-6518 | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-6805 | |
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 |
Principal Investigator: | Kenneth H. Cowan, MD, PhD | University of Nebraska |
Study ID Numbers: | CDR0000582980, UNMC-31106 |
Study First Received: | April 24, 2008 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00666731 History of Changes |
Health Authority: | Unspecified |
male breast cancer breast cancer ductal breast carcinoma in situ lobular breast carcinoma in situ atypical ductal breast hyperplasia |
Carcinoma, Lobular Hyperplasia Skin Diseases Breast Neoplasms, Male Precancerous Conditions Carcinoma in Situ |
Breast Neoplasms Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Breast Cancer, Male Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Skin Diseases |
Precancerous Conditions Breast Neoplasms Breast Diseases |