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

Breast Cancer Clinical Trial

Official title:

Pilot Study for Analysis of Tumor Gene Expression by DNA Microarray Analysis in Patients Undergoing Breast Cancer Surgery or Core Biopsy Sampling

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898937
• Other study ID #: CDR0000377341
• Secondary ID: P50CA058185P30CA
• Status: Terminated
• First received: May 9, 2009
• Last updated: April 12, 2018
• Start date: September 1999
• Est. completion date: July 2017

Study information

• Verified date: February 2018
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: July 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Gene Expression as Assessed by RNA Microarray Analysis	Concentration of RNA recovered from breast needle biopsies	1 day