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

October 7, 2023 updated by: University of Nebraska

Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4945

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Penrose Cancer Center
  - Denver, Colorado, United States, 80210
    - Centura - Porter Adventist Hospital
  - Lakewood, Colorado, United States, 80228
    - Centura - St. Anthony Hospital
  - Parker, Colorado, United States, 80138
    - Centura - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - Centura - St. Mary Corwin Medical Center
- Florida
  - Daytona Beach, Florida, United States, 32117
    - Florida Hospital Memorial Medical Center
  - Daytona Beach, Florida, United States, 32114
    - Halifax Health Medical Center
  - Daytona Beach, Florida, United States, 32127
    - Hlaifax Health Medical Center
  - DeLand, Florida, United States, 32720
    - Florida Hospital DeLand
  - Orange City, Florida, United States, 32763
    - Florida Hospital FISH
  - Ormond Beach, Florida, United States, 32174
    - Halifax Health Medical Center
  - Palm Coast, Florida, United States, 32164
    - Florida Hospital Flagler
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Anderson, Indiana, United States, 46011
    - Community Clinical Research Center
  - Anderson, Indiana, United States, 46011
    - Community Hospital of Anderson and Madison County, Inc
  - Anderson, Indiana, United States, 46011
    - Community Cancer Care
  - Indianapolis, Indiana, United States, 46227
    - Community Cancer Center South
  - Indianapolis, Indiana, United States, 46256
    - Community Cancer Center North
  - Indianapolis, Indiana, United States, 46219
    - Community Health Network
- Iowa
  - Council Bluffs, Iowa, United States, 51503
    - Methodist Jennie Edmundson Hospital
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center
  - Davenport, Iowa, United States, 52804
    - Iowa Cancer Specialists
  - Mason City, Iowa, United States, 50401
    - Mercy Medical Center, North Iowa
  - Spencer, Iowa, United States, 51301
    - Abben Cancer Center
  - Waterloo, Iowa, United States, 50702
    - Covenant Medical Center, Inc
- Kansas
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's Cancer Instititue, South
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University
- Maine
  - Lewiston, Maine, United States, 04240
    - Maine Research Associates
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center, Bennett Breast Care Center
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center, Cynthia A. Rydhom Cancer Treatment Center
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center, Hematology Oncology Associates
- Maryland
  - Hagerstown, Maryland, United States, 21742
    - Meritus Center for Clinical Research
  - Westminster, Maryland, United States, 21157
    - William E Kahlert Regional Cancer Center
- Massachusetts
  - Holyoke, Massachusetts, United States, 01040
    - Holyoke Medical Center
  - Plymouth, Massachusetts, United States, 02360
    - Beth Israel Deaconess Hospital
- Missouri
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital - Joplin
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute
  - Kansas City, Missouri, United States, 64086
    - Saint Luke's Cancer Institute - East
  - Kansas City, Missouri, United States, 64118
    - Saint Luke's Cancer Institute - Kansas City North
  - Liberty, Missouri, United States, 64068
    - Saint Luke's Cancer Institute - Liberty
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center dba Mosaic Life Care
  - Saint Joseph, Missouri, United States, 64507
    - Heartland Regional Medical Center dba Cancer Care, St. Joseph, Mosaic Life Care
- Nebraska
  - Hastings, Nebraska, United States, 68901
    - Mary Lanning Healthcare/Morrison Cancer Center
  - Kearney, Nebraska, United States, 68847
    - Good Samaritan Hospital/Cancer Center
  - Norfolk, Nebraska, United States, 68701
    - Faith Regional Health Services, Carson Cancer Center
  - North Platte, Nebraska, United States, 69101
    - Great Plains Regional Medical Center
  - Omaha, Nebraska, United States, 68198-6805
    - UNMC Eppley Cancer Center, University of Nebraska Medical Center
  - Scottsbluff, Nebraska, United States, 69361
    - Regional West Health Services
- New York
  - Glens Falls, New York, United States, 12801
    - C.R. Wood Cancer Center, Glens Falls Hospital
  - Utica, New York, United States, 13501
    - Faxton St. Lukes (St. Elizabeth campus)
  - Utica, New York, United States, 13502
    - Faxton St. Luke's Healthcare (Mohawk Valley Health Systems)
  - Utica, New York, United States, 13502
    - Faxton St. Luke's Healthcare (St. Luke's Campus)
- North Carolina
  - Fayetteville, North Carolina, United States, 28304
    - Cape Fear Valley Health System
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Hospital Cancer Care Center
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Avera Medical Group Oncology and Hematology Aberdeen
  - Mitchell, South Dakota, United States, 57301
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Center
- Vermont
  - Rutland, Vermont, United States, 05701
    - Rutland Regional Medical Center
- Wisconsin
  - Brookfield, Wisconsin, United States, 53045
    - Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital
  - Franklin, Wisconsin, United States, 53132
    - Wheaton Franciscan Healthcare - Reiman Cancer Care
  - Racine, Wisconsin, United States, 53405
    - Wheaton Franciscan Healthcare - All Saints
  - Wauwatosa, Wisconsin, United States, 53226
    - Wheaton Franciscan Healthcare - Wauwatosa Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

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

Description

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers Time Frame: Ongoing	Web-based registry	Ongoing
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.	Ongoing
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.	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2006

Primary Completion (Actual)

August 19, 2016

Study Completion (Actual)

August 19, 2016

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimated)

April 25, 2008

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

0311-06-EP
P30CA036727 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Collaborating centers may ask other centers to participate in future studies. Only shared among centers belonging to the BCCR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.