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ERG Protein Expression in Prostatic Adenocarcinoma and Its Clinicopathological Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04825691
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Information provided by (Responsible Party):
Aya Mohammed Amin, Assiut University

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

Condition or disease Intervention/treatment
Prostate Adenocarcinoma 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : May 4, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : May 23, 2023

Resource links provided by the National Library of Medicine

Group/Cohort 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

Primary Outcome Measures :
  1. Evaluation the ERG expression in prostatic acinar adenocarcinoma [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Correlation between ERG expression with clinicopathological features. [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All cases diagnosed as prostatic acinar adenocarcinoma.

Inclusion Criteria:

  • All cases diagnosed as prostatic acinar adenocarcinoma

Exclusion Criteria:

  • Other types of prostatic cancer.
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Responsible Party: Aya Mohammed Amin, demonstrator, Assiut University Identifier: NCT04825691    
Other Study ID Numbers: ERG protein in cancer prostate
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type