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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05811546
Collaborator
(none)
68
Enrollment
1
Location
32
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Immunohistochemical staining for DNMT1 and EZH2

Study Design

Study Type:
Observational
Anticipated Enrollment :
68 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
H. pylori Gastritis specimens

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.
Non-H. pylori Gastritis specimens
Gastric carcinoma specimens

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aliyah Soliman Ali, Pathology resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05811546
Other Study ID Numbers:
  • Epigenetics Gastric Carcinoma
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms

Study Results

No Results Posted as of Apr 13, 2023