Expanded Breast Cancer Registry and Tissue Repository

Breast Cancer Clinical Trial

Official title:

Expanded Breast Cancer Registry and Tissue Repository

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00322894
• Other study ID #: INST 0552C
• Status: Active, not recruiting
• Start date: February 16, 2006
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. 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.

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 (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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: August 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess clinico-pathologiv variables and outcomes	Utilize the Extended Breast Cancer Repository clinical database to determine the relationship between clinico-pathologic variables and patient outcomes.	10 years
Primary	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	Establish a centralized tissue repository	Establish a centralized tissue repository (breast and related tissues) to serve as a resource for current and future scientific studies.	4 years

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center