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

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT00666731

Collaborator

National Cancer Institute (NCI) (NIH)

4,945

Enrollment

Locations

123

Actual Duration (Months)

76.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Precancerous Condition	Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: Excess human biological tissue Procedure: quality-of-life assessment

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 Design

Study Type:

Observational

Actual Enrollment :

4945 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Outcome Measures

Primary Outcome Measures

Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers [Ongoing]
Web-based registry
Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC [Ongoing]
Web-based registries.
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 [Ongoing]
Web-based registry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Penrose Cancer Center	Colorado Springs	Colorado	United States	80907
2	Centura - Porter Adventist Hospital	Denver	Colorado	United States	80210
3	Centura - St. Anthony Hospital	Lakewood	Colorado	United States	80228
4	Centura _ Parker Adventist Hospital	Parker	Colorado	United States	80138
5	Centura - St. Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
6	Halifax Health Medical Center	Daytona Beach	Florida	United States	32114
7	Florida Hospital Memorial Medical Center	Daytona Beach	Florida	United States	32117
8	Hlaifax Health Medical Center	Daytona Beach	Florida	United States	32127
9	Florida Hospital Deland	DeLand	Florida	United States	32720
10	Florida Hospital FISH	Orange City	Florida	United States	32763
11	Halifax Health Medical Center	Ormond Beach	Florida	United States	32174
12	Florida Hospital Flagler	Palm Coast	Florida	United States	32164
13	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
14	Trinity Medical Center	Moline	Illinois	United States	61265
15	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
16	Community Cancer Care	Anderson	Indiana	United States	46011
17	Community Clinical Research Center	Anderson	Indiana	United States	46011
18	Community Hospital of Anderson and Madison County, Inc	Anderson	Indiana	United States	46011
19	Community Health Network	Indianapolis	Indiana	United States	46219
20	Community Cancer Center South	Indianapolis	Indiana	United States	46227
21	Community Cancer Center North	Indianapolis	Indiana	United States	46256
22	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa	United States	51503
23	Genesis Medical Center	Davenport	Iowa	United States	52804
24	Iowa Cancer Specialists	Davenport	Iowa	United States	52804
25	Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
26	Abben Cancer Center	Spencer	Iowa	United States	51301
27	Covenant Medical Center, Inc	Waterloo	Iowa	United States	50702
28	Saint Luke's Cancer Instititue - South	Overland Park	Kansas	United States	66213
29	Tulane University	New Orleans	Louisiana	United States	70112
30	Central Maine Medical Center - Hematology Oncology Associates	Lewiston	Maine	United States	04240
31	Central Maine Medical Center _ Bennett Breast Care Center	Lewiston	Maine	United States	04240
32	Central Maine medical Center _ Cynthia A. Rydhom Cancer Treatment Center	Lewiston	Maine	United States	04240
33	Central Maine Medical Center	Lewiston	Maine	United States	04240
34	Maine Research Associates	Lewiston	Maine	United States	04240
35	Meritus Center for Clinical Research	Hagerstown	Maryland	United States	21742
36	William E Kahlert Regional Cancer Center	Westminster	Maryland	United States	21157
37	Holyoke Medical Center	Holyoke	Massachusetts	United States	01040
38	Beth Israel Deaconess Hospital	Plymouth	Massachusetts	United States	02360
39	Mercy Hospital - Joplin	Joplin	Missouri	United States	64804
40	Saint Luke's Cancer Institute - East	Kansas City	Missouri	United States	64086
41	Saint Luke's Cancer Institute	Kansas City	Missouri	United States	64111
42	Saint Luke's Cancer Institute - Kansas City North	Kansas City	Missouri	United States	64118
43	Saint Luke's Cancer Institute - Liberty	Liberty	Missouri	United States	64068
44	Heartland Regional Medical Center dba Mosaic Life Care	Saint Joseph	Missouri	United States	64506
45	Heartland Regional Medical Center dba Cancer Care, St. Joseph, Mosaic Life Care	Saint Joseph	Missouri	United States	64507
46	Mary Lanning Healthcare/Morrison Cancer Center	Hastings	Nebraska	United States	68901
47	Good Samaritan Hospital/Cancer Center	Kearney	Nebraska	United States	68847
48	Faith Regional Health Services, Carson Cancer Center	Norfolk	Nebraska	United States	68701
49	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69101
50	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-6805
51	Regional West Health Services	Scottsbluff	Nebraska	United States	69361
52	C.R. Wood Cancer Center, Glens Falls Hospital	Glens Falls	New York	United States	12801
53	Faxton St. Lukes (St. Elizabeth campus)	Utica	New York	United States	13501
54	Faxton St. Luke's Healthcare (Mohawk Valley Health Systems)	Utica	New York	United States	13502
55	Faxton St. Luke's Healthcare (St. Luke's Campus)	Utica	New York	United States	13502
56	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28304
57	Trinity Hospital Cancer Care Center	Minot	North Dakota	United States	58701
58	Avera Medical Group Oncology and Hematology Aberdeen	Aberdeen	South Dakota	United States	57401
59	Avera Cancer Institute	Mitchell	South Dakota	United States	57301
60	Avera Cancer Center	Sioux Falls	South Dakota	United States	57105
61	Rutland Regional Medical Center	Rutland	Vermont	United States	05701
62	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin	United States	53045
63	Wheaton Franciscan Healthcare - Reiman Cancer Care	Franklin	Wisconsin	United States	53132
64	Wheaton Franciscan Healthcare - All Saints	Racine	Wisconsin	United States	53405
65	Wheaton Franciscan Healthcare - Wauwatosa Cancer Care	Wauwatosa	Wisconsin	United States	53226