Microbiome Analysis in Gastric Intestinal Metaplasia and in Gastric Cancer and Subtypes Correlation

April 24, 2020 updated by: George Pappas-Gogos, University Hospital, Ioannina

Microbiome Analysis in Patients With Gastric Intestinal Metaplasia and in Patients With Gastric Cancer and Correlation With the Subtypes of the Lesions

The aim of the study will be to analyze the microbiome in the blood and stomach in patients with intestinal metaplasia (IM) and / or gastric cancer (GC). As far as IM is concerned, it has been found that the incomplete type is related to GC mainly intestinal-type. Studies show differences in the microbiome in patients with IM and in patients with GC, but do not specify whether these differences are related to histological types.

Our intention is to further analyze the microbiome based on histological types. Most studies on stomach cancer have focused on the microbiota of gastric microbiota. Recent data have shown that the microbiome of the small intestine, especially the mucosa, can play a key role in the condition of the gastrointestinal tract. Disturbance of the microbiome of the small intestine has been found in celiac disease, chronic liver disease, diabetes and irritable bowel syndrome. However, information on the role of the microbiome in IM remains limited.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Review of research area Intestinal metaplasia of the stomach (IM) is generally considered a precancerous lesion and is associated with a small increase in the risk of developing gastric cancer (GC). Endoscopic monitoring has been proposed to control the risk of endangered populations. However, due to the lower incidence of GC in the United States and other Western countries, there is no specific monitoring protocol. In general, there are no widely accepted guidelines for IM management. Recently, the European Endoscopic Society as well as other European academic companies have developed documented guidelines for the management of patients with IM.

These guidelines emphasize the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases of high-grade dysplasia. Risk factors for IM include Helicobacter pylori infection, high NaCl intake, smoking, alcohol consumption and chronic biliary reflux.

The development of intestinal-type gastric carcinoma occurs in four stages: non-atrophic gastritis, multifocal atrophic gastritis, IM, and dysplasia. The IM of the gastric cardia and the Barrett's esophagus differ in the risk of malignancy. Elevated serum pepsinogen levels have been suggested as an indicator of extensive gastric atrophy. Currently, there are no reliable markers of gastric dysplasia or gastric cancer.

Based on the available data, it appears that the IM of the gastric cardia is a possible precursor to the development of intestinal-type carcinoma of the stomach. It has been found that 45% of patients with gastric carcinoma had residual IM, supporting the idea that IM is a particularly important precursor to its development. Histologically, the IM may be complete or incomplete. Complete (type I) intestinal metaplasia is defined by the mucosa of the small intestinal type with mature absorbent cells, cell cups, and a brush-like outline. Incomplete intestinal metaplasia (type II) secretes cialomycin and is similar to colonic epithelium with columns of "intermediate" cells at various stages of differentiation, irregular mucosal droplets and the absence of a "brush" limit. The highest risk of gastric cancer is associated with incomplete and / or extensive IM.

Recent studies show that microbial changes are related to the histological stages of gastric oncogenesis. Chronic H. pylori infection can cause inflammation of the mucosa and cause histological changes. It is also recognized as an important risk factor for GC. However, only 3% of patients infected with H. pylori develop GC. In addition, H. pylori has been found to be usually undetectable in GC samples. These studies suggest that H. pylori infection may only be an early event for the gastric mucosa, which will undergo further oncogenic changes and indicate the possible role of mucosal microbes, with the exception of H. pylori in the gastric carcinoma.

The dominant germ type in the gastric mucosa was found to be protein-secreted bacteria, in both H. pylori negative and positive for H. pylori samples. Two previous studies have shown that the microbial count in IM patients was found to be partially overlapped with the group of gastritis and cancer among patients with H. pylori infection. Li et al (2017) found that the microbial amount in gastritis samples overlapped mostly with that of IM samples. In contrast, the microflora of patients with IM and GC had significantly lower microbial richness, while the biodiversity of the microbiology of patients with overt gastritis (EG), chronic gastritis (CG) and IM was similar in total, with the exception of those with GC. These conflicting results suggest that IM may be the key point in microbial change and that there may be other qualitative factors involved in gastric oncogenesis, especially in patients with IM.

Research subject and objectives The study will be performed on patients undergoing gastroscopy who have IM and / or GC findings. In patients with IM, the microbiome will be analyzed and correlated with the type of IM (complete-incomplete). The same will be done for patients with GC (intestinal-type cancer).

Thematic area The aim of the study will be to analyze the microbiome in the blood and stomach in patients with intestinal metaplasia (IM) and / or gastric cancer (GC). As far as IM is concerned, it has been found that the incomplete type is related to GC mainly intestinal-type. Studies show differences in the microbiome in patients with IM and in patients with GC, but do not specify whether these differences are related to histological types.

Our intention is to further analyze the microbiome based on histological types. Most studies on stomach cancer have focused on the microbiota of gastric microbiota. Recent data have shown that the microbiome of the small intestine, especially the mucosa, can play a key role in the condition of the gastrointestinal tract. Disturbance of the microbiome of the small intestine has been found in celiac disease, chronic liver disease, diabetes and irritable bowel syndrome. However, information on the role of the microbiome in IM remains limited.

Keywords Gastric intestinal metaplasia, Complete Type, Incomplete Type, Gastric Cancer, Microbiome

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioánnina, Greece, 45500
        • University Hospital of Ioannina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric intestinal metaplasia and/or gastric cancer, and healthy controls

Description

Inclusion Criteria:

  • Patients with gastric intestinal metaplasia and/or gastric cancer
  • Healthy controls

Exclusion Criteria:

  • Metabolic syndrome and its components
  • IBD
  • Autoimmune diseases
  • Otherwise tumours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complete type
Patients with complete-type intestinal metaplasia
Procedure: Gastroscopy
Upper GI endoscopy and biopsy
Incomplete type
Patients with incomplete-type intestinal metaplasia
Procedure: Gastroscopy
Upper GI endoscopy and biopsy
Controls
Healthy subjects
Procedure: Gastroscopy
Upper GI endoscopy and biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of microbiome in subtypes of intestinal metaplasia and gastric cancer
Time Frame: Through study completion, an average of 1 year.
Microbiome analysis with complete and incomplete type of intestinal metaplasia and subtypes of gastric cancer
Through study completion, an average of 1 year.
Analysis of microbiome in subtypes of intestinal metaplasia and gastric cancer
Time Frame: Through study completion, an average of 1 year.
Microbiome correlation with complete and incomplete type of intestinal metaplasia and subtypes of gastric cancer
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ioannina

Collaborators

University of Ioannina

Investigators

  • Study Director: Konstantinos Vlachos, Prof, University of Ioannina
  • Principal Investigator: George Pappas-Gogos, Dr, University Hospital, Ioannina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2020

Primary Completion (Anticipated)

September 14, 2020

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

2021-2023

IPD Sharing Access Criteria

Researchers who would access data, statistics and results of this study in order to perform similar studies

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Gastroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe