Clinical trial NCT00666731: Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
Official title: Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Precancerous Condition
Keywords: male breast cancer
breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
atypical ductal breast hyperplasia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-25
Enrollment: 4945
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 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)
2. 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 )
3. Age 19 or greater
4. Able to provide informed consent

Brief 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.

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers
timeFrame: Ongoing
measure: Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC
timeFrame: Ongoing
measure: 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
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Denver
country: United States
facility: Centura - Porter Adventist Hospital
state: Colorado
city: Lakewood
country: United States
facility: Centura - St. Anthony Hospital
state: Colorado
city: Parker
country: United States
facility: Centura - Parker Adventist Hospital
state: Colorado
city: Pueblo
country: United States
facility: Centura - St. Mary Corwin Medical Center
state: Colorado
city: Daytona Beach
country: United States
facility: Halifax Health Medical Center
state: Florida
city: Daytona Beach
country: United States
facility: Florida Hospital Memorial Medical Center
state: Florida
city: Daytona Beach
country: United States
facility: Hlaifax Health Medical Center
state: Florida
city: DeLand
country: United States
facility: Florida Hospital Deland
state: Florida
city: Orange City
country: United States
facility: Florida Hospital FISH
state: Florida
city: Ormond Beach
country: United States
facility: Halifax Health Medical Center
state: Florida
city: Palm Coast
country: United States
facility: Florida Hospital Flagler
state: Florida
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Moline
country: United States
facility: Trinity Medical Center
state: Illinois
city: Yorkville
country: United States
facility: Rush-Copley Healthcare Center
state: Illinois
city: Anderson
country: United States
facility: Community Cancer Care
state: Indiana
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Anderson
country: United States
facility: Community Hospital of Anderson and Madison County, Inc
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Community Cancer Center South
state: Indiana
city: Indianapolis
country: United States
facility: Community Cancer Center North
state: Indiana
city: Council Bluffs
country: United States
facility: Methodist Jennie Edmundson Hospital
state: Iowa
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Davenport
country: United States
facility: Iowa Cancer Specialists
state: Iowa
city: Mason City
country: United States
facility: Mercy Medical Center, North Iowa
state: Iowa
city: Spencer
country: United States
facility: Abben Cancer Center
state: Iowa
city: Waterloo
country: United States
facility: Covenant Medical Center, Inc
state: Iowa
city: Overland Park
country: United States
facility: Saint Luke's Cancer Instititue, South
state: Kansas
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center, Bennett Breast Care Center
state: Maine
city: Lewiston
country: United States
facility: Central Maine Medical Center, Cynthia A. Rydhom Cancer Treatment Center
state: Maine
city: Lewiston
country: United States
facility: Central Maine Medical Center, Hematology Oncology Associates
state: Maine
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Lewiston
country: United States
facility: Maine Research Associates
state: Maine
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Westminster
country: United States
facility: William E Kahlert Regional Cancer Center
state: Maryland
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Beth Israel Deaconess Hospital
state: Massachusetts
city: Joplin
country: United States
facility: Mercy Hospital - Joplin
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute - East
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute - Kansas City North
state: Missouri
city: Liberty
country: United States
facility: Saint Luke's Cancer Institute - Liberty
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center dba Mosaic Life Care
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center dba Cancer Care, St. Joseph, Mosaic Life Care
state: Missouri
city: Hastings
country: United States
facility: Mary Lanning Healthcare/Morrison Cancer Center
state: Nebraska
city: Kearney
country: United States
facility: Good Samaritan Hospital/Cancer Center
state: Nebraska
city: Norfolk
country: United States
facility: Faith Regional Health Services, Carson Cancer Center
state: Nebraska
city: North Platte
country: United States
facility: Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: UNMC Eppley Cancer Center, University of Nebraska Medical Center
state: Nebraska
city: Scottsbluff
country: United States
facility: Regional West Health Services
state: Nebraska
city: Glens Falls
country: United States
facility: C.R. Wood Cancer Center, Glens Falls Hospital
state: New York
city: Utica
country: United States
facility: Faxton St. Lukes (St. Elizabeth campus)
state: New York
city: Utica
country: United States
facility: Faxton St. Luke's Healthcare (Mohawk Valley Health Systems)
state: New York
city: Utica
country: United States
facility: Faxton St. Luke's Healthcare (St. Luke's Campus)
state: New York
city: Fayetteville
country: United States
facility: Cape Fear Valley Health System
state: North Carolina
city: Minot
country: United States
facility: Trinity Hospital Cancer Care Center
state: North Dakota
city: Aberdeen
country: United States
facility: Avera Medical Group Oncology and Hematology Aberdeen
state: South Dakota
city: Mitchell
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Center
state: South Dakota
city: Rutland
country: United States
facility: Rutland Regional Medical Center
state: Vermont
city: Brookfield
country: United States
facility: Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital
state: Wisconsin
city: Franklin
country: United States
facility: Wheaton Franciscan Healthcare - Reiman Cancer Care
state: Wisconsin
city: Racine
country: United States
facility: Wheaton Franciscan Healthcare - All Saints
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Healthcare - Wauwatosa Cancer Care
state: Wisconsin
Study officials:
affiliation: University of Nebraska
name: Kenneth H Cowan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: