Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
1 other identifier
observational
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 13, 2023
March 1, 2023
2.7 years
March 31, 2023
March 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
H. pylori Gastritis specimens
Non-H. pylori Gastritis specimens
Gastric carcinoma specimens
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
Biospecimen
Formalin-fixed-paraffin-embedded tissue specimens.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pathology resident
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 13, 2023
Study Start
May 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
April 13, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share