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Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis

Primary Purpose

Chronic Gastritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immunohistochemical detection of Heparanase in chronic gastritis
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Gastritis focused on measuring Heparanase, Chronic Gastritis, Helicobacter Pylori

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with symptomatic chronic gastritis who underwent upper endoscopy.

Exclusion Criteria:

  • patients with gastric carcinoma.

Sites / Locations

  • Maisa Hashem Mohammed

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with chronic gastritis

Arm Description

patients with symptomatic chronic gastritis will undergo upper endoscopy, gastric biopsies will be obtained to establish giagnosis of chronic gastritis, detection of h.pylori and assessment of heparanase expression.

Outcomes

Primary Outcome Measures

Correlation of Heparanase expression in chronic gastritis.
we will correlate the intensity and percentage of immunohistochemical expression of Heparanase to different parameters of chronic gastritis as severity of gastric atrophy, chronic inflammation, intensity of neutrophilic infiltrate and presence or absence of H. pylori.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2021
Last Updated
January 25, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05073614
Brief Title
Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis
Official Title
Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Treatment of H.pylori may not be achieved in many patients with chronic gastritis. Termination of the inflammatory respose produced by h.pylori may be useful in management of difficult cases. Heparanase is a pro-inflammatory mediator. Blocking of heparanase may relief the symptoms of chronic gastritis.
Detailed Description
Chronic gastritis (CG) is a very common disease. The incidence of CG is not accurately known. However, it is clear that the incidence of CG is increasing by advancing age. CG is divided into two main types; type A or immune and type B or non-immune gastritis. Both types of CG share the same histological features. However, type A is less common, usually affects the gastric fundus in a diffuse manner and separates the antrum. on the contrary; type B or non-immune CG, which is by far more common, inevitably develops in the antrum and progresses proximally. H. pylori-induced CG usually requires antibiotic therapy to eradicate the causative organism and subsequently terminate the inflammatory response and the symptoms of gastritis. However, eradication of H. pylori is difficult to be achieved in many patients. Previous studies established that there is a vicious circle between H. pylori-infected gastric epithelial cells and the gastric mucosal inflammatory cells. Heparanase (HPSE) is a mammalian ᵦ-endoglucoronidase. HPSE plays a critical role in multiple inflammatory processes by degrading and remodeling heparan sulfate polysaccharide chains in the extracellular matrix (ECM). This leads to release of multiple cytokines and chemokines which are located in the ECM. HPSE is a drug target, three inhibitors of this enzyme have been tested in early stage clinical trials. Many studies reported that the expression of HPSE is up-regulated in a variety of inflammatory conditions as ulcerative colitis, acute pancreatitis, acute vasculitis and sepsis. The aim of this work is to evaluate the role of heparanase (HPSE) in chronic gastritis (CG) by correlating the expression of HPSE to different histological features of CG as presence of H. pylori, chronic inflammatory infiltrate, gastric atrophy, intestinal metaplasia and neutrophil infiltrate (activity), to detect new treatment modalities in CG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gastritis
Keywords
Heparanase, Chronic Gastritis, Helicobacter Pylori

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with chronic gastritis will undergo upper endoscopy, punch biopsies will be obtained and tissue sections will be prepared from each specimen. sections will be stained by H&E to establish diagnosis of chronic gastritis. others will be stained by Giemsa staain to detect H.pylori, still others will be stained immunohistochemically by anti Heparanase antibody.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with chronic gastritis
Arm Type
Other
Arm Description
patients with symptomatic chronic gastritis will undergo upper endoscopy, gastric biopsies will be obtained to establish giagnosis of chronic gastritis, detection of h.pylori and assessment of heparanase expression.
Intervention Type
Genetic
Intervention Name(s)
immunohistochemical detection of Heparanase in chronic gastritis
Intervention Description
immunohistochemical detection of Heparanase in chronic gastritis specimens.
Primary Outcome Measure Information:
Title
Correlation of Heparanase expression in chronic gastritis.
Description
we will correlate the intensity and percentage of immunohistochemical expression of Heparanase to different parameters of chronic gastritis as severity of gastric atrophy, chronic inflammation, intensity of neutrophilic infiltrate and presence or absence of H. pylori.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with symptomatic chronic gastritis who underwent upper endoscopy. Exclusion Criteria: patients with gastric carcinoma.
Facility Information:
Facility Name
Maisa Hashem Mohammed
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis

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