Expanded Breast Cancer Registry and Tissue Repository

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
State of New Mexico
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00322894
First received: May 5, 2006
Last updated: December 5, 2013
Last verified: December 2013
  Purpose
  1. 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).
  2. To collect relevant demographics including age, menopausal status, race/ethnicity, BMI, place of residence, behaviors (smoking, alcohol intake, etc)
  3. 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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Identify risk factors for breast cancer [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Prospectively collect demographic, risk factor, diagnosis and treatment data and tissues (blood, buccal cells and tumor if appicable) for breast cancer patients seen at the UNM Cancer Center to assist in identification of unique factors that may impact patient prognosis in this population.


Secondary Outcome Measures:
  • Establish a centralized tissue repository [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Establish a centralized tissue repository (breast and related tissues) to serve as a resource for current and future scientific studies.


Other Outcome Measures:
  • Assess clinico-pathologiv variables and outcomes [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Utilize the Extended Breast Cancer Repository clinical database to determine the relationship between clinico-pathologic variables and patient outcomes.


Biospecimen Retention:   Samples With DNA

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 2016
Estimated Primary Completion Date: October 2015 (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
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: NCT00322894

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
State of New Mexico
Investigators
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: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Breast cancer, risk factors, treatment, clinico-pathologic factors, outcomes, tissue repository

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

ClinicalTrials.gov processed this record on July 28, 2014