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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by University of Nebraska
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00666731
First received: April 24, 2008
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    Web-based registry.


Biospecimen Retention:   Samples With DNA

Tissue, blood


Estimated Enrollment: 999999
Study Start Date: October 2006
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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.
    Other: study of socioeconomic and demographic variables
    Repository
    Procedure: Excess human biological tissue
    Tissue procurement.
    Procedure: quality-of-life assessment
    Cancer care.
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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666731

Contacts
Contact: Elizabeth "Liz" Fleissner, RN BSN 402-559-8197 eafleissner@unmc.edu
Contact: Marsha Ketcham, RN OCN 402-559-5286 mketcham@unmc.edu

Locations
United States, Colorado
Penrose Cancer Center Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Jodi Harr, Clinical Research Manager    (719) 776-5270    jodiharr@centura.org   
Contact: Marth Brown, R.N.         
Principal Investigator: Kate Crow, MS CGC         
United States, Massachusetts
Holyoke Medical Center Recruiting
Holyoke, Massachusetts, United States, 01040
Contact: Maureen Nomakeo, R.N.    413-534-2500    Nomakeo_Maureen@holyokehealth.com   
Contact: Lynn Downey, RHIT, CTR         
Principal Investigator: Zubeena Mateen, M.D.         
St. Vincent Hospital Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Pamela Sigel, R.N.    (508) 363-7018    enzo.centofanti@stvincenthospital.com   
Contact: Enzo Centofanti, Exec Director       enzo.centofanti@stvincenthospital.com   
Principal Investigator: James Rooney, M.D.         
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Natalie Nielsen    308-398-6518      
Contact: Mary Gulzow    308-398-6518      
Principal Investigator: Mehmet Copur, M.D.         
Good Samaritan Hospital/Cancer Center Recruiting
Kearney, Nebraska, United States, 68847
Contact: Judy Mullen, LPN    308-865-7564    judymullen@catholichealth.net   
Contact: Connie Wittman         
Principal Investigator: George Bascom, M.D.         
St. Elizabeth's Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Amy Akins, R.N.    402-219-7912    kpribnow@stez.org   
Contact: Paul Edwards, Coordinator         
Principal Investigator: Kevin Yiee, M.D.         
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Liz Fleissner, RN BSN    402-559-8197    eafleissner@unmc.edu   
Contact: Alice Kueh, Coordinator    402-559-8511    akueh@unmc.edu   
Principal Investigator: Kenneth Cowan, M.D., Ph.D.         
United States, South Dakota
Avera Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Cheryl Ageton, R.N., CCRC    605-322-3095      
Principal Investigator: Amy Krie, M.D.         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Kenneth H. Cowan, MD, PhD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth Cowan, M.D., Ph.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00666731     History of Changes
Other Study ID Numbers: 311-06, P30CA036727, UNMC-31106
Study First Received: April 24, 2008
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
male breast cancer
breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:
Breast Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014