Collecting and Storing Tissue Samples From Women With or Without Breast Cancer (NCT00899301)

Study 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.

Read the 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 studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,520

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Patients with and without breast cancer.

Eligibility 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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 4,000 participants (estimated)
Patient registry: No

Groups and cohorts

Patients with Breast Cancer
Other: biologic sample preservation procedure
Patients without breast cancer
Other: biologic sample preservation procedure

Interventions

Otherbiologic sample preservation procedure
Tissue, urine and blood collection.

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6838, United States
- Clinical Trials Office - Vanderbilt-Ingram Cancer Center · Contact · 800-811-8480
Recruiting

References and documents

Registry details

Key details

Study ID: NCT00899301
Lead sponsor: Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: A Bapsi Chakravarthy, MD (Professor of Radiation Oncology, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted: May 12, 2009
Start date: Jan 22, 2004
Primary completion: Mar 2027 (estimated)
Completion: Mar 2027 (estimated)
Last update: Aug 25, 2026

Study contacts

VICC Clinical Trials Information Program

Contact

800-811-8480

A. Bapsi Chakravarthy, MD

principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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