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

Breast Tissue/Body Fluids Repository

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00899301

Enrollment

4000

Registered

2009-05-12

Start date

2004-01-22

Completion date

2027-03-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

Brief summary

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.

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.

Interventions

OTHERbiologic sample preservation procedure

Tissue, urine and blood collection.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

Design outcomes

Primary

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	5 years

Countries

United States

Contacts

CONTACTVICC Clinical Trials Information Program

800-811-8480

PRINCIPAL_INVESTIGATORA. Bapsi Chakravarthy, MD

Vanderbilt-Ingram Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026