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Breast Cancer Registry for Pa...

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

Last Updated: 2023-10-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

4945 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-12

Study Completion Date

2016-08-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Precancerous Condition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

study of socioeconomic and demographic variables

Repository

Intervention Type OTHER

Excess human biological tissue

Tissue procurement.

Intervention Type PROCEDURE

quality-of-life assessment

Cancer care.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth H Cowan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Penrose Cancer Center

Colorado Springs, Colorado, United States

Site Status

Centura - Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Centura - St. Anthony Hospital

Lakewood, Colorado, United States

Site Status

Centura - Parker Adventist Hospital

Parker, Colorado, United States

Site Status

Centura - St. Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

Halifax Health Medical Center

Daytona Beach, Florida, United States

Site Status

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Site Status

Hlaifax Health Medical Center

Daytona Beach, Florida, United States

Site Status

Florida Hospital Deland

DeLand, Florida, United States

Site Status

Florida Hospital FISH

Orange City, Florida, United States

Site Status

Halifax Health Medical Center

Ormond Beach, Florida, United States

Site Status

Florida Hospital Flagler

Palm Coast, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Trinity Medical Center

Moline, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status

Community Cancer Care

Anderson, Indiana, United States

Site Status

Community Clinical Research Center

Anderson, Indiana, United States

Site Status

Community Hospital of Anderson and Madison County, Inc

Anderson, Indiana, United States

Site Status

Community Health Network

Indianapolis, Indiana, United States

Site Status

Community Cancer Center South

Indianapolis, Indiana, United States

Site Status

Community Cancer Center North

Indianapolis, Indiana, United States

Site Status

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Site Status

Genesis Medical Center

Davenport, Iowa, United States

Site Status

Iowa Cancer Specialists

Davenport, Iowa, United States

Site Status

Mercy Medical Center, North Iowa

Mason City, Iowa, United States

Site Status

Abben Cancer Center

Spencer, Iowa, United States

Site Status

Covenant Medical Center, Inc

Waterloo, Iowa, United States

Site Status

Saint Luke's Cancer Instititue, South

Overland Park, Kansas, United States

Site Status