Assessment of Candidate Protein Expression in Breast Cancer Specimens

Breast Cancer Clinical Trial

Official title:

Assessment of Candidate Protein Expression in Human Breast Cancer Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918892
• Other study ID #: CASE1108
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: September 23, 2021

Study information

• Verified date: July 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential expression of candidate genes between normal and cancer breast tissues	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

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database