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OpenTrials
Completed

NCT Number: NCT00918892

Assessment of Candidate Protein Expression in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

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

immunohistochemistry staining method

Other

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

laboratory biomarker analysis

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Assessment of Candidate Protein Expression in Human Breast Cancer Specimens

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2009
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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