Assessment of Candidate Protein Expression in Breast Cancer Specimens

July 29, 2022 updated by: Case Comprehensive Cancer Center

Assessment of Candidate Protein Expression in Human Breast Cancer Specimens

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine if candidate genes display differential expression between normal and cancer breast tissues.

OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Study Type

Observational

Enrollment (Actual)

460

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
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Description

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • Tissue samples available

  • Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:

    • Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
    • ER-positive/PR-positive/ HER2-positive by FISH
    • ER-negative/PR-negative/HER2-positive
    • ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Exclusion Criteria:

  • There are no exclusion criteria in this protocol

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
Differential expression of candidate genes between normal and cancer breast tissues
Time Frame: non-applicable
Approximately 5 slides of each tumor will be collected to provide sufficient samples for replicate staining, if necessary, as well as a staining for a positive control
non-applicable

Collaborators and Investigators

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

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Stefanie Avril, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

January 1, 2011

Primary Completion (Actual)

September 23, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE1108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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