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

Sponsor

Vanderbilt-Ingram Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00899301

Collaborator

National Cancer Institute (NCI) (NIH)

4,000

Enrollment

Location

266

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: biologic sample preservation procedure

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Breast Tissue/Body Fluids Repository

Actual Study Start Date :

Jan 1, 2004

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with Breast Cancer	Other: biologic sample preservation procedure Tissue, urine and blood collection.
Patients without breast cancer	Other: biologic sample preservation procedure Tissue, urine and blood collection.

Arm

Intervention/Treatment

Patients with Breast Cancer

Other: biologic sample preservation procedure

Tissue, urine and blood collection.

Patients without breast cancer

Other: biologic sample preservation procedure

Tissue, urine and blood collection.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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