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

April 12, 2018 updated by: Georgetown University

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

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.

Study Overview

Status

Terminated

Conditions

Breast Cancer

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Any woman undergoing a breast biopsy or breast surgery

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Gene Expression as Assessed by RNA Microarray Analysis Time Frame: 1 day	Concentration of RNA recovered from breast needle biopsies	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Claudine Isaacs, MD, Lombardi Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria