Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04365946
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2020-04-22
Brief Title:
Microbiome Analysis in Gastric Intestinal Metaplasia and in Gastric Cancer and Subtypes Correlation
Sponsor:
University Hospital Ioannina
Organization:
University Hospital Ioannina
Study Overview
Official Title:
Microbiome Analysis in Patients With Gastric Intestinal Metaplasia and in Patients With Gastric Cancer and Correlation With the Subtypes of the Lesions
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Barretts 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
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 Barretts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None