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Gene Expression in Tumor Tissue From Women Undergoing Surgery for Breast Cancer or Core Biopsy of the Breast

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898937
Recruitment Status : Terminated (Funding ended)
First Posted : May 12, 2009
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:

RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more about the genes and proteins found in breast tissue.

PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women undergoing surgery for breast cancer or core biopsy of the breast.


Condition or disease Intervention/treatment
Breast Cancer Genetic: microarray analysis Procedure: breast biopsy

Detailed Description:

OBJECTIVES:

  • Assess tumor gene expression information from women undergoing surgery for breast cancer or core biopsy sampling of the breast.

OUTLINE: This is a pilot study.

Tumor tissue is collected and analyzed for tumor gene expression by DNA microarray analysis for research studies.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Design
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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study for Analysis of Tumor Gene Expression by DNA Microarray Analysis in Patients Undergoing Breast Cancer Surgery or Core Biopsy Sampling
Study Start Date : September 1999
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Genetic: microarray analysis
    tumor specimen will be assessed by microarray analysis
  • Procedure: breast biopsy
    A breast biopsy will be done to obtain a tumor specimen

Outcome Measures
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Primary Outcome Measures :
  1. Tumor Gene Expression as Assessed by RNA Microarray Analysis [ Time Frame: 1 day ]
    Concentration of RNA recovered from breast needle biopsies


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any woman undergoing a breast biopsy or breast surgery
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing surgery for breast cancer OR core biopsy sampling of the breast

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898937


Locations
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United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Claudine Isaacs, MD Lombardi Comprehensive Cancer Center
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00898937    
Other Study ID Numbers: CDR0000377341
P50CA058185 ( U.S. NIH Grant/Contract )
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-99225
First Posted: May 12, 2009    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018
Last Verified: February 2018
Keywords provided by Georgetown University:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases