NCT00322894

Brief Summary

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. 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. 2.To collect relevant demographics including age, menopausal status, race/ethnicity, body mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2016

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

10.5 years

First QC Date

May 5, 2006

Last Update Submit

May 20, 2025

Conditions

Breast Cancer

Keywords

Breast cancerRisk factorsTreatmentClinico-pathologicOutcomesTissue repositoryRegistry

Outcome Measures

Primary Outcomes (1)

  • Identify risk factors for breast cancer

    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.

    4 years

Secondary Outcomes (1)

  • Establish a centralized tissue repository

    4 years

Other Outcomes (1)

  • Assess clinico-pathologiv variables and outcomes

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Not specified.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Melanie Royce, MD

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 8, 2006

Study Start

February 16, 2006

Primary Completion

August 2, 2016

Study Completion

March 31, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)