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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05811546
Other study ID # Epigenetics Gastric Carcinoma
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Immunohistochemical staining for DNMT1 and EZH2
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.

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in DNMT1 and EZH2 expression. 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. two years
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