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Expanded Breast Cancer Registry and Tissue Repository

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322894
First Posted: May 8, 2006
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of New Mexico
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
May 5, 2006
May 8, 2006
September 19, 2017
February 2006
June 2018   (Final data collection date for primary outcome measure)
Identify risk factors for breast cancer [ Time Frame: 4 years ]
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.
Not Provided
Complete list of historical versions of study NCT00322894 on ClinicalTrials.gov Archive Site
Establish a centralized tissue repository [ Time Frame: 4 years ]
Establish a centralized tissue repository (breast and related tissues) to serve as a resource for current and future scientific studies.
Not Provided
Assess clinico-pathologiv variables and outcomes [ Time Frame: 10 years ]
Utilize the Extended Breast Cancer Repository clinical database to determine the relationship between clinico-pathologic variables and patient outcomes.
Not Provided
 
Expanded Breast Cancer Registry and Tissue Repository
Expanded Breast Cancer Registry and Tissue Repository

The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals are to improve the outcomes and quality of life of patients with breast cancer, and ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an infrastructure that can potentially be adopted as a model for a statewide registry and tissue repository for the discovery of biomarkers for this disease.

The goals of the EBCR are:

  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 (Quallity of Life, etc).
  2. To collect relevant demographics including age, menopausal status, race/ethnicity, body mass index (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 protocol), which will be stored in the Tissue Bank Shared Resource Facility for future hypothesis-driven research.
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 (EBCR) 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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Other
20 Years
Retention:   Samples With DNA
Description:
Sample of tumor, buccal cells and blood collected at the time of study enrollment.
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.
Breast Cancer
Not Provided
Not Provided
Not Provided
 
Active, not recruiting
500
December 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients diagnosed with breast cancer, regardless of gender, ethnicity/race, stage of disease or treatment, are eligible.
  • Patients must be less than or equal to one year from diagnosis of non-metastatic breast cancer OR less than or equal to one year from initiation of treatment for metastatic disease.
  • Pathological diagnosis of breast cancer
  • Expected availability of clinical follow up data
  • Eighteen years old or older
  • Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Not specified.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00322894
INST 0552C
Yes
Not Provided
Plan to Share IPD: No
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
University of New Mexico
Principal Investigator: Melanie Royce, MD University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
September 2017