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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00899301
First received: May 9, 2009
Last updated: July 14, 2014
Last verified: July 2014
  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 Intervention
Breast Cancer
Other: biologic sample preservation procedure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Tissue/Body Fluids Repository

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: January 2004
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with and without breast cancer.

Criteria
  • Any subject > 18 years of age with a breast lesion which is suspected to be cancer or a known breast cancer lesion (primary or metastatic) who agrees to donate tissue/body fluids. Collection of samples can occur:
  • At the time of breast biopsy or surgery for benign disease
  • At the time of breast biopsy or surgery for suspected breast cancer
  • At the time of biopsy or surgery for histologically proven breast cancer at any stage of disease.
  • From archival materials
  • In a normal volunteer who wishes to donate blood and/or urine to allow for a control population against whom the cancer patient can be compared
  • Subjects have to sign informed consent for study of tumor specimens as part of a research project.
  • Patients have to give permission for their tumor specimens to be obtained from outside institutions for molecular analyses.
  • All subjects participating in this protocol have to be willing to be followed for recurrence, relapse and death from disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899301

Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clnical Trials Information Program    800-811-8480      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clnical Trials Information Program    800-811-8480      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
Principal Investigator: Mark Kelley, MD, FACS Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00899301     History of Changes
Other Study ID Numbers: VICC BRE 03103, P30CA068485, VU-VICC-BRE-03103, VU-VICC-030747
Study First Received: May 9, 2009
Last Updated: July 14, 2014
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014