Collecting and Storing Tissue Samples From Women With or Without Breast Cancer

August 26, 2025 updated by: A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Breast Tissue/Body Fluids Repository

RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer.

PURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To create a database that includes environmental, demographic, phenotypic, clinical, pathologic, genetic, and prognostic factors in large cohorts of women with different stages of breast cancer.
  • To create a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens.

OUTLINE: Patients undergo tumor tissue and normal tissue sample collection at the time of medically indicated surgery or biopsy. Archival tissue may also be collected. Patients and normal volunteers also undergo blood and urine sample collection. A repository of tissue, blood, and urine samples will be established to facilitate current and future research studies to learn about the biologic features of breast cancer development and progression. Research studies may include molecular pathology studies and gene and protein expression studies.

Patients' medical records are reviewed over approximately 5 years to determine if the test results are associated with health status. Patients do not receive the results of individual testing.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: VICC Clinical Trials Information Program
  • Phone Number: 800-811-8480

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Clinical Trials Office - Vanderbilt-Ingram Cancer Center
          • Phone Number: 800-811-8480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with and without breast cancer.

Description

  • Breast lesion which is suspected to be cancer or a known diagnosis of breast cancer (any stage, at any point in the disease trajectory) who agrees to donate tissue/body fluids.
  • Individuals of all races and ethnic groups are eligible for this trial. There is no restriction regarding age, race, or ethnicity. The trial is open to the accrual of men and women.
  • Must sign informed consent for study of tumor specimens as part of a research project.
  • Must give permission for their tumor specimens to be obtained from outside institutions for molecular analyses.
  • Must be willing to be followed for recurrence, relapse and death from disease.

ELIGIBILITY CRITERIA FOR OPTIONAL PHYSICAL FUNCTION AND COGNITIVE ASSESSMENTS

  • Must be 60 years of age or older
  • Have completed initial round of cancer treatment
  • Have completed the optional online survey and opted-in for the physical function and cognitive assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Breast Cancer
Other: biologic sample preservation procedure
Tissue, urine and blood collection.
Patients without breast cancer
Other: biologic sample preservation procedure
Tissue, urine and blood collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creation of a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2004

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC BRE 03103
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-BRE-03103
  • VU-VICC-030747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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