Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma

Recruiting

• Conditions: Gastric Carcinoma
• Interventions: Diagnostic Test: Immunohistochemical staining for DNMT1 and EZH2

• Registration Number: NCT05811546
• Lead Sponsor: Assiut University

Brief Summary

The goal of this cross-sectional study is to evaluate epigenetic modifications in gastric carcinogenesis, mainly in H. pylori gastritis vs gastric carcinoma. The main question\[s\] it aims to answer are:

* How does H. pylori infection cause gastric cancer?

* Can DNA methylation and other epigenetic changes predict and affect the development of gastric cancer? Formalin-fixed-paraffin-embedded tissue specimens will be obtained and reviewed for comparison between epigenetic changes in H. pylori gastritis and gastric adenocarcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis with:
• Available full clinical data: (age, sex, complaint, findings in clinical examination).
• Full data of previous endoscopy and radiology.

Exclusion Criteria

• Cases of diffuse type gastric carcinoma.
• Any case of gastric cancer, H. Pylori associated gastritis, non-H. Pylori gastritis, benign gastric lesions with missing clinical, endoscopic, radiologic or follow-up data.
• Cases with no available H&E stained slides or formalin fixed paraffin embedded block.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
H. pylori Gastritis specimens	Immunohistochemical staining for DNMT1 and EZH2	-

Primary Outcome Measures

Name	Time	Method
Difference in DNMT1 and EZH2 expression.	two years	Histopathological evaluation of routine H\&E slides and immunohistochemical markers to compare the intensity and extent of epigenetic changes in both H. Pylori associated gastritis and gastric carcinoma.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt