Chronic GastritisNCT05073614
Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis
A study testing immunohistochemical detection of Heparanase in chronic gastritis in people with Chronic Gastritis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Gastritis
- What is being tested?
- immunohistochemical detection of Heparanase in chronic gastritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with symptomatic chronic gastritis who underwent upper endoscopy.
Who cannot join
- patients with gastric carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Gastritis
- Being tested
- immunohistochemical detection of Heparanase in chronic gastritis
- Keywords
- Heparanase, Chronic Gastritis, Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical detection of Heparanase in chronic gastritisGenetic
immunohistochemical detection of Heparanase in chronic gastritis specimens.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: immunohistochemical detection of Heparanase in chronic gastritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic GastritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Hashem Mohammed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073614
- Sponsor's protocol ID
- Soh-Med-21-09-43
- Status last verified
- Jan 2022
- First submitted
- 19 Sep 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis
- ClinicalTrials.gov ID
- NCT05073614
- Acronym / sponsor ID
- Soh-Med-21-09-43
- Conditions
- Chronic Gastritis
- Keywords
- Heparanase, Chronic Gastritis, Helicobacter Pylori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients with chronic gastritis | Other | Genetic: immunohistochemical detection of Heparanase in chronic gastritispatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptomatic chronic gastritis who underwent upper endoscopy.
Key exclusion criteria (1 listed)
- patients with gastric carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemical detection of Heparanase in chronic gastritisimmunohistochemical detection of Heparanase in chronic gastritis specimens. | Genetic | patients with chronic gastritis |
Primary outcome
Correlation of Heparanase expression in chronic gastritis.
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunohistochemical detection of Heparanase in chronic gastritis in people with Chronic Gastritis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Heparanase expression in chronic gastritis. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.