Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
Condition: Breast Cancer; Precancerous Condition
MeSH terms: Breast Neoplasms; Precancerous Conditions
Study type: Observational

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.
    

Intervention name(s): medical chart review; questionnaire administration; study of socioeconomic and demographic variables; Excess human biological tissue; quality-of-life assessment
Intervention type(s): Other; Other; Other; Procedure; Procedure
Intervention description(s): 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.; 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.; Repository; Tissue procurement.; Cancer care.
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
      
Biospecimen description: 
      Tissue, blood
    
Keywords: male breast cancer; breast cancer; ductal breast carcinoma in situ; lobular breast carcinoma in situ; atypical ductal breast hyperplasia