Expanded Breast Cancer Registry and Tissue Repository
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
- To register patients diagnosed with breast cancer and information relevant to their diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery, radiation, chemotherapy, hormone therapy, etc), and survivorship (QoL, etc).
- To collect relevant demographics including age, menopausal status, race/ethnicity, BMI, place of residence, behaviors (smoking, alcohol intake, etc)
- To establish a paired tumor tissue and blood sample for each relevant time-point (as defined in the full protocol), which will be stored in the Tissue Bank Shared Resource Facility for future hypothesis driven research.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort |
| Target Follow-Up Duration: | 20 Years |
| Official Title: | Expanded Breast Cancer Registry and Tissue Repository |
Sample of tumor, buccal cells and blood collected at the time of study enrollment.
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Institutions and/or physicians are required to report each new diagnosis of breast cancer to the New Mexico Tumor Registry (NMTR). The NMTR is a valuable database that provides information on breast cancer, including trends in incidence and survival. However, relevant information on breast cancer prognosis and treatment is either not routinely collected or not readily available to the NMTR. We propose to establish an Expanded Breast Cancer Registry and Tissue Repository at this institution that could serve as an infrastructure for collection of this information. Furthermore, a tissue bank will be established for collection of paired tissue (tumor, buccal cells and blood sample) from patients diagnosed with breast cancer who consent to providing excess/extra tissue and additional blood for the Tissue Repository. This tissue bank will serve as a repository from which researchers can access tissue samples to conduct laboratory-based studies of genetic determinants of breast cancer risks, prognosis and survival in women with breast cancer seen in this institution.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All patients diagnosed with breast cancer during the study period commencing January 2006, regardless of gender, ethnicity/race, stage of disease or treatment.
Inclusion Criteria:
- All patients diagnosed with breast cancer during the study period commencing January 2006, regardless of gender, ethnicity/race, stage of disease or treatment, are eligible.
- Potential study participants must meet the eligibility criteria found in the Eligibility Checklist. The Eligibility Checklist must be completed and stored on site. Eligibility is confirmed during registration by answering, "yes" to the question, "Have all eligibility criteria been met?" on the Registration Form.
- For the current proposal, we intend to include only breast cancer patients. However, the investigators hope to eventually include the following groups: 1) Participants at intermediate to high risk for breast cancer (documented BRCA or other genetic syndromes for breast cancer, atypical hyperplasia or LCIS, modified Gail score >1.66), and 2) Healthy volunteers (no history of cancer). When the infrastructure and funding is set-up to include these participants, an amended protocol will be submitted for HRRC review.
Exclusion Criteria:
- Not specified.
Contacts and Locations| Contact: Angela W Meisner, MPH | 505-272-2422 | awmeisner@salud.unm.edu |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Ann Parsons 505-925-0371 aparsons@salud.unm.edu | |
| Principal Investigator: Melanie Royce, MD | |
| Principal Investigator: | Melanie Royce, MD | University of New Mexico Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT00322894 History of Changes |
| Other Study ID Numbers: | INST 0552C |
| Study First Received: | May 5, 2006 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013