Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325891
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-16
Brief Title:
Microbiota in Gastric Cancer by Gastric Mucosal Brushing
Sponsor:
King Chulalongkorn Memorial Hospital
Organization:
King Chulalongkorn Memorial Hospital
Study Overview
Official Title:
Microbiota Diversity and Composition in Gastric Cancer by Gastric Mucosal Brushing a Cross-sectional Case-control Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process particularly in patients with gastric cancer However there has been no analysis of gastric microbiota using the mucosal brushing technique despite its favoring benefit in microbiota study Therefore this study aims to evaluate microbiota profile in patients with gastric cancer compared to those without gastric cancer by using mucosal brush sampling This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling
Detailed Description:
Gut microbiota play role in mucosal immune response and strength gut integrity The dysbiosis or imbalance of microbiota changes microecology and activates the inflammation in gastrointestinal mucosa It also has been implicated in gastric carcinogenesis
Up to date many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process particularly in patients with gastric cancer Although Helicobacter pylori infection is potential class I carcinogen in initial step of gastric carcinogenesis only between 1 and 3 of patient with H pylori infection develop gastric cancer In addition many current studies have revealed significant change in microbiome profile of patient with H pylori-negative gastric cancers Many studies have revealed significant change in microbiome profile of patient with H pylori-negative gastric cancers Therefore the investigators have hypothesized that unidentified non-H pylori bacteria play a role in gastric cancer development
However most of current studies of gastric microbiota in patients with gastric cancer have been conducted in Eastern Asia particularly in China and Korea there is still no published data from Thailand Moreover all previous studies have used gastric tissue biopsy method There has been no analysis of gastric microbiota using the mucosal brushing technique despite its favoring benefit in microbiota study
This study is pilot phase cross-sectional and case-control study that aims to evaluate microbiota profile in patients with gastric cancer compared to those without gastric cancer by using mucosal brush sampling
According to previous studies H pylori had significant impact on the composition of gastric microbiota Presence of H pylori could affect the result of the study Therefore pre-specified subgroup analysis of Hpylori infection and non-Hpylori infection will be perform
Study protocol include
Age gender BMI smoking history history of PPI use within 3 months history of infection within 2 weeks history of antibiotic use within 3months history of probiotic use within 3months history of intraabdominal surgery history of dietary supplement and herbal use will be recorded in case record form
After consent standard EGD will be performed
The gastric mucosa using mucosal brushing with sterile sheathed brush gastric mucosal biopsy by standard forceps biopsy and rapid urease test for evaluate Hpylori status will be done respectively
The gastric mucosal specimen will be keep in sterile tube and immediate keep in freezing at -80C allow room temperature 2 hr for 16sRNA sequencing analysis
Up to date many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process particularly in patients with gastric cancer Although Helicobacter pylori infection is potential class I carcinogen in initial step of gastric carcinogenesis only between 1 and 3 of patient with H pylori infection develop gastric cancer In addition many current studies have revealed significant change in microbiome profile of patient with H pylori-negative gastric cancers Many studies have revealed significant change in microbiome profile of patient with H pylori-negative gastric cancers Therefore the investigators have hypothesized that unidentified non-H pylori bacteria play a role in gastric cancer development
However most of current studies of gastric microbiota in patients with gastric cancer have been conducted in Eastern Asia particularly in China and Korea there is still no published data from Thailand Moreover all previous studies have used gastric tissue biopsy method There has been no analysis of gastric microbiota using the mucosal brushing technique despite its favoring benefit in microbiota study
This study is pilot phase cross-sectional and case-control study that aims to evaluate microbiota profile in patients with gastric cancer compared to those without gastric cancer by using mucosal brush sampling
According to previous studies H pylori had significant impact on the composition of gastric microbiota Presence of H pylori could affect the result of the study Therefore pre-specified subgroup analysis of Hpylori infection and non-Hpylori infection will be perform
Study protocol include
Age gender BMI smoking history history of PPI use within 3 months history of infection within 2 weeks history of antibiotic use within 3months history of probiotic use within 3months history of intraabdominal surgery history of dietary supplement and herbal use will be recorded in case record form
After consent standard EGD will be performed
The gastric mucosa using mucosal brushing with sterile sheathed brush gastric mucosal biopsy by standard forceps biopsy and rapid urease test for evaluate Hpylori status will be done respectively
The gastric mucosal specimen will be keep in sterile tube and immediate keep in freezing at -80C allow room temperature 2 hr for 16sRNA sequencing analysis
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