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

Vanderbilt University Medical Center

Status

Enrolling

Conditions

Breast Cancer

Treatments

Other: biologic sample preservation procedure

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00899301

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-BRE-03103

VU-VICC-030747

VICC BRE 03103

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,000 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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