NCT00899301

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

Breast Tissue/Body Fluids Repository

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	biologic sample preservation procedure	Tissue, urine and blood collection.

Timeline

• Start date: 2004-01-22
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2009-05-12
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States