Assessment of Candidate Protein Expression in Breast Cancer Specimens

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00918892
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Study Start: 2011-01-01
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differential expression of candidate genes between normal and cancer breast tissues	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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States