A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer

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A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2009
First Received: April 24, 2008 Last Updated: April 18, 2009 History of Changes
Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00666731
Purpose
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
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers [ Designated as safety issue: No ]

Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: October 2006
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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 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.

Eligibility

Ages Eligible for Study: 19 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666731

Locations
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

Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenneth H. Cowan, MD, PhD University of Nebraska

More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database

No publications provided

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

Keywords provided by National Cancer Institute (NCI):
male breast cancer
breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
atypical ductal breast hyperplasia

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms by Site
Skin Diseases
Precancerous Conditions
Neoplasms
Breast Neoplasms
Breast Diseases