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

Breast Cancer Clinical Trial

— BCCR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666731
• Other study ID #: 0311-06-EP
• Secondary ID: P30CA036727
• Status: Completed
• Start date: October 12, 2006
• Est. completion date: August 19, 2016

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4945
• Est. completion date: August 19, 2016
• Est. primary completion date: August 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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:

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• 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.
• 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.
• study of socioeconomic and demographic variables
Repository

Procedure:
• Excess human biological tissue
Tissue procurement.
• quality-of-life assessment
Cancer care.

Locations

Country	Name	City	State
United States	Avera Medical Group Oncology and Hematology Aberdeen	Aberdeen	South Dakota
United States	Community Cancer Care	Anderson	Indiana
United States	Community Clinical Research Center	Anderson	Indiana
United States	Community Hospital of Anderson and Madison County, Inc	Anderson	Indiana
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa
United States	Genesis Medical Center	Davenport	Iowa
United States	Iowa Cancer Specialists	Davenport	Iowa
United States	Florida Hospital Memorial Medical Center	Daytona Beach	Florida
United States	Halifax Health Medical Center	Daytona Beach	Florida
United States	Hlaifax Health Medical Center	Daytona Beach	Florida
United States	Florida Hospital Deland	DeLand	Florida
United States	Centura - Porter Adventist Hospital	Denver	Colorado
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Wheaton Franciscan Healthcare - Reiman Cancer Care	Franklin	Wisconsin
United States	C.R. Wood Cancer Center, Glens Falls Hospital	Glens Falls	New York
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Mary Lanning Healthcare/Morrison Cancer Center	Hastings	Nebraska
United States	Holyoke Medical Center	Holyoke	Massachusetts
United States	Community Cancer Center North	Indianapolis	Indiana
United States	Community Cancer Center South	Indianapolis	Indiana
United States	Community Health Network	Indianapolis	Indiana
United States	Mercy Hospital - Joplin	Joplin	Missouri
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	Saint Luke's Cancer Institute - East	Kansas City	Missouri
United States	Saint Luke's Cancer Institute - Kansas City North	Kansas City	Missouri
United States	Good Samaritan Hospital/Cancer Center	Kearney	Nebraska
United States	Centura - St. Anthony Hospital	Lakewood	Colorado
United States	Central Maine Medical Center	Lewiston	Maine
United States	Central Maine Medical Center, Bennett Breast Care Center	Lewiston	Maine
United States	Central Maine Medical Center, Cynthia A. Rydhom Cancer Treatment Center	Lewiston	Maine
United States	Central Maine Medical Center, Hematology Oncology Associates	Lewiston	Maine
United States	Maine Research Associates	Lewiston	Maine
United States	Saint Luke's Cancer Institute - Liberty	Liberty	Missouri
United States	Mercy Medical Center, North Iowa	Mason City	Iowa
United States	Trinity Hospital Cancer Care Center	Minot	North Dakota
United States	Avera Cancer Institute	Mitchell	South Dakota
United States	Trinity Medical Center	Moline	Illinois
United States	Tulane University	New Orleans	Louisiana
United States	Faith Regional Health Services, Carson Cancer Center	Norfolk	Nebraska
United States	Great Plains Regional Medical Center	North Platte	Nebraska
United States	UNMC Eppley Cancer Center, University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital FISH	Orange City	Florida
United States	Halifax Health Medical Center	Ormond Beach	Florida
United States	Saint Luke's Cancer Instititue, South	Overland Park	Kansas
United States	Florida Hospital Flagler	Palm Coast	Florida
United States	Centura - Parker Adventist Hospital	Parker	Colorado
United States	Beth Israel Deaconess Hospital	Plymouth	Massachusetts
United States	Centura - St. Mary Corwin Medical Center	Pueblo	Colorado
United States	Wheaton Franciscan Healthcare - All Saints	Racine	Wisconsin
United States	Rutland Regional Medical Center	Rutland	Vermont
United States	Heartland Regional Medical Center dba Cancer Care, St. Joseph, Mosaic Life Care	Saint Joseph	Missouri
United States	Heartland Regional Medical Center dba Mosaic Life Care	Saint Joseph	Missouri
United States	Regional West Health Services	Scottsbluff	Nebraska
United States	Avera Cancer Center	Sioux Falls	South Dakota
United States	Abben Cancer Center	Spencer	Iowa
United States	Faxton St. Luke's Healthcare (Mohawk Valley Health Systems)	Utica	New York
United States	Faxton St. Luke's Healthcare (St. Luke's Campus)	Utica	New York
United States	Faxton St. Lukes (St. Elizabeth campus)	Utica	New York
United States	Covenant Medical Center, Inc	Waterloo	Iowa
United States	Wheaton Franciscan Healthcare - Wauwatosa Cancer Care	Wauwatosa	Wisconsin
United States	William E Kahlert Regional Cancer Center	Westminster	Maryland
United States	Rush-Copley Healthcare Center	Yorkville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers	Web-based registry	Ongoing
Primary	Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC	Web-based registries.	Ongoing
Primary	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	Web-based registry.	Ongoing