ERG Protein Expression in Prostatic Adenocarcinoma and Its Clinicopathological Features

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04825691
Collaborator
(none)
50
24.6

Study Details

Study Description

Brief Summary

Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Immunohistochemistry of prostate biopsy

Detailed Description

Prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. The burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. Although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (IHC) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. Out of these markers, Ets-related gene (ERG product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors ERG-transmembrane protease, serine 2 fusion. ERG is a transcription factor belonging to the erythroblast transformation-specific (ETS) family. It is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. This proto-oncogene is expressed in the urogenital tract and hematopoietic cells. Gene fusions involving sequences of transmembrane protease serine 2 (promoter of TMPRSS2) and protein coding sequences of ERG result in over expression of ERG in prostatic tumors. This TMPRSS2-ERG fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. Genetic rearrangements were not identified in epithelial carcinomas until Tomlins et al. demonstrated ERG gene fusions in prostatic carcinoma.The presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma.

TMPRSS2-ERG fusion results in constitutive expression of ERG oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. Moreover, TMPRSS2-ERG fusion gene product can be an important therapeutic target in prostatic cancer. Immunohistochemical (IHC) expression of ERG oncoprotein may serve as a surrogate biomarker of TMPRSS2-ERG fusion gene. Therefore in the present study we aimed to evaluate the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
ERG Protein Expression in Prostatic Acinar Adenocarcinoma and Its Correlation With Clinicopathological Features
Anticipated Study Start Date :
May 4, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
May 23, 2023

Arms and Interventions

Arm Intervention/Treatment
cases diagnosed as prostatic acinar adenocarcinoma

Diagnostic Test: Immunohistochemistry of prostate biopsy
Sections of formalin fixed paraffin embedded tissue blocks will be stained with ERG oncoprotein. Antibody dilution, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions

Outcome Measures

Primary Outcome Measures

  1. Evaluation the ERG expression in prostatic acinar adenocarcinoma [3 days]

Secondary Outcome Measures

  1. Correlation between ERG expression with clinicopathological features. [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All cases diagnosed as prostatic acinar adenocarcinoma
Exclusion Criteria:
  • Other types of prostatic cancer.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aya Mohammed Amin, demonstrator, Assiut University
ClinicalTrials.gov Identifier:
NCT04825691
Other Study ID Numbers:
  • ERG protein in cancer prostate
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021