Recruiting

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

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT00899301

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

biologic sample preservation procedure

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT00899301

Start date

Jan 22, 2004

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Breast Cancer

Patients without breast cancer

Interventions

biologic sample preservation procedure

Tissue, urine and blood collection.

Primary outcome measure

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 and Locations

Central contacts

VICC Clinical Trials Information Program

800-811-8480

Locations

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232-6838

Contacts

Clinical Trials Office - Vanderbilt-Ingram Cancer Center

800-811-8480

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-08-25.