Expanded Breast Cancer Registry and Tissue Repository - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00322894

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Expanded Breast Cancer Registry and Tissue Repository

Further study details as provided by University of New Mexico:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Sample of tumor, buccal cells and blood collected at the time of study enrollment.

Estimated Enrollment:	50
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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

Study Population

All patients diagnosed with breast cancer during the study period commencing January 2006, regardless of gender, ethnicity/race, stage of disease or treatment.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322894

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Melanie Royce, MD

University of New Mexico

More Information

Responsible Party:	University of New Mexico - CRTC ( Melanie Royce, MD; Principal Investigator )
Study ID Numbers:	INST 0552C
Study First Received:	May 5, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00322894
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009