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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Georgetown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00898937
First received: May 9, 2009
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Breast Cancer
Genetic: microarray analysis
Procedure: breast biopsy
Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Tumor gene expression as assessed by DNA microarray analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    tumor sample will be assessed by DNA microarray


Estimated Enrollment: 100
Study Start Date: September 1999
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT00898937

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Claudine Isaacs, MD    202-444-3677    isaacsc@georgetown.edu   
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Claudine Isaacs, MD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00898937     History of Changes
Other Study ID Numbers: CDR0000377341, P50CA058185, P30CA051008, GUMC-99225
Study First Received: May 9, 2009
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
breast cancer

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

ClinicalTrials.gov processed this record on July 10, 2014