BCCR Project

For the successful implementation of multi-center Breast Cancer studies, a close information partnership between multiple centers with expertise in Breast Cancer epidemiology, genetics, biology, early detection and patient care has to be established.

The registry’s goals are:

1. To establish a comprehensive data and biospecimen bank. 
2. To provide core support services for multidisciplinary research on breast cancer carried out by members of the Eppley Breast Cancer Research Group (EBCRG) as well as research collaborators from different participating institutions/centers.

The general study design involves:

1. Development of the Web-based Breast Cancer Collaborative Registry (BCCR) as a repository for socio-demographic, environmental, clinical and family history, and biospecimen data collected at UNMC/NMC and other IRB approved sites for individuals with a personal history of breast cancer, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)  and/or 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 ) and to merge UNMC data already being collected on breast cancer patients under the Adult Oncology Data Collection Study (IRB#310-05).
2. Standardization of clinical, environmental, socio-demographic, and family history data for breast cancer-related information to be collected and shared for research purposes by EBCRG breast cancer research collaborators as well as research collaborators from different participating institutions/centers.
3. After clinical pathology review by the Nebraska Medical Center (NMC) Pathology Department, procurement and banking of excess biological materials (breast tissue, tumor tissue and/or metastatic breast cancer tissue and/or paraffin embedded tissue) from registry participants with breast disease including breast cancer and non-malignant breast disease for future analysis that will be proposed in future IRB submissions by means of either providing a link to the clinical accession number of the sample(s) stored  by the NMC Pathology Department Procurement, or for storage in the UNMC Solid Tumor Bank (under the guidelines in IRB #281-96).
4. Voluntary collection and banking of blood, serum, and urine on registry participants for future analysis that will be proposed in future IRB submissions.
5. Periodic follow-up with on living and deceased registry participants to update relevant health histories and family histories.
6. Establish a high-risk cohort for future research into the molecular and biological bases of breast cancer susceptibility and interventional trials.
7. Establish a future national breast cancer registry by sharing information collected for research purposes only in the BCCR to be used by breast cancer research collaborators from other institutions.

BCCR participants with a personal history of breast cancer, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)  and/or 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) will be asked to participate in the registry. Patients with a history of breast cancer who were treated at UNMC/NMC clinics and who are deceased will be added to the BCCR database. The information provided by participants will be placed in a secured database and participant’s confidentiality will be protected. This will be achieved by storing the information in a coded fashion in the registry. Identifiers will never be released in order to protect participant confidentiality.  Individuals who do not currently qualify for any studies will be asked for permission to contact them in the future, in the event of any new information or studies that develop that would be relevant to their personal and/or family situation. Data collection will be achieved through a combination of self administered questionnaires and telephone or in person structured interviews conducted by study coordinators.

Medical records and pathology reports will also be reviewed with permission.

Registry participants will be asked about their willingness to store the information collected on them in the Breast Cancer Collaborative Registry. This registry is housed at Eppley Cancer Institute at the University of Nebraska Medical Center’s. The information provided to this registry will be collected for research purposes only, and will be used by EBCRG and future breast cancer research collaborators. .