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

Vanderbilt-Ingram Cancer Center4,000 enrolled

Overview

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.

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

4,000

Conditions

Breast Cancer

Interventions

biologic sample preservation procedureOTHER

Tissue, urine and blood collection.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

VICC Clinical Trials Information Program

CONTACT

800-811-8480

Data from ClinicalTrials.gov

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