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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

May 9, 2009
July 14, 2014
January 2004
January 2016   (final data collection date for 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 ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Creation of a database that includes environmental, demographic, phenotypic, clinical, pathologic, genetic, and prognostic factors in large cohorts of women with different stages of breast cancer [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899301 on ClinicalTrials.gov Archive Site
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Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
Breast Tissue/Body Fluids Repository

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with and without breast cancer.

Breast Cancer
Other: biologic sample preservation procedure
Tissue, urine and blood collection.
  • Patients with Breast Cancer
    Intervention: Other: biologic sample preservation procedure
  • Patients without breast cancer
    Intervention: Other: biologic sample preservation procedure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
January 2016
January 2016   (final data collection date for primary outcome measure)
  • 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.
Female
18 Years and older
Yes
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
NCT00899301
VICC BRE 03103, P30CA068485, VU-VICC-BRE-03103, VU-VICC-030747
No
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
Principal Investigator: Mark Kelley, MD, FACS Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP