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

NCT ID: NCT05811546

Condition: Gastric Carcinoma

Conditions: Official terms:
Carcinoma
Stomach Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Diagnostic Test
Intervention name: Immunohistochemical staining for DNMT1 and EZH2
Description: Immunohistochemical staining for DNMT1 and EZH2 using rabbit monoclonal/polycolonal antibodies with immunoperoxidase staining will be used as a visualization method. Antibodies dilutions, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions.
Arm group label: H. pylori Gastritis specimens

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.

Criteria for eligibility:

Study pop:
Formalin-fixed-paraffin-embedded tissue blocks from resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis.

Sampling method: Probability Sample
Criteria:
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.

Gender: All

Minimum age: 30 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: Assiut University

Address:
City: Assiut
Zip: 71515
Country: Egypt

Status: Recruiting

Contact:
Last name: Mahmoud Sherif, Phd

Phone: +20 1002763939
Email: m.farouk.pathology@aun.edu.eg

Start date: May 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05811546

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