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

Breast Cancer Clinical Trial

Official title:

Breast Tissue/Body Fluids Repository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899301
• Other study ID #: VICC BRE 03103
• Secondary ID: P30CA068485VU-VI
• Status: Recruiting
• Start date: January 2004
• Est. completion date: March 2026

Study information

• Verified date: August 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: VICC Clinical Trials Information Program
• Phone: 800-811-8480
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• biologic sample preservation procedure
Tissue, urine and blood collection.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial