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

May 5, 2006
December 5, 2013
February 2006
October 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00322894 on ClinicalTrials.gov Archive Site
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.
Not Provided
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.
Not Provided
 
Expanded Breast Cancer Registry and Tissue Repository
Expanded Breast Cancer Registry and Tissue Repository
  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.

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.

Observational [Patient Registry]
Observational Model: Cohort
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
October 2016
October 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322894
INST 0552C
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
State of New Mexico
Principal Investigator: Melanie Royce, MD University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP