NCT05073614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

September 19, 2021

Last Update Submit

January 25, 2022

Conditions

Keywords

HeparanaseChronic GastritisHelicobacter Pylori

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

patients with chronic gastritis

OTHER

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.

Genetic: immunohistochemical detection of Heparanase in chronic gastritis

Interventions

immunohistochemical detection of Heparanase in chronic gastritis specimens.

patients with chronic gastritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with symptomatic chronic gastritis who underwent upper endoscopy.

You may not qualify if:

  • patients with gastric carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisa Hashem Mohammed

Sohag, 82524, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pathology

Study Record Dates

First Submitted

September 19, 2021

First Posted

October 11, 2021

Study Start

July 1, 2021

Primary Completion

December 30, 2021

Study Completion

January 1, 2022

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations