Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Patients with Breast Cancer |
|
|
| Patients without breast cancer |
|
Recruiting Locations
Nashville, Tennessee 37232-6838
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
800-811-8480
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
VICC Clinical Trials Information Program800-811-8480
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.