Microbiota in Gastric Cancer by Gastric Mucosal Brushing

NCT ID: NCT06325891

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-05-31

Brief Summary

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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

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* 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 H.pylori infection and non-H.pylori 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 H.pylori 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.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control group

* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy
* Patients with no or minimal upper GI symptoms and current EGD appear normal or minimal gastritis

Gastric mucosal brushing

Intervention Type DIAGNOSTIC_TEST

Gastric mucosal brushing will be performed at body of stomach in control group and non-tumorous area of body in gastric cancer group. If gastric body area could not feasible (eg. tumor involvement), then gastric antrum and more proximal part of body will be sampling.

Gastric mucosal biopsy

Intervention Type DIAGNOSTIC_TEST

Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.

Gastric cancer group

* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy
* Patients with pathological diagnosis of high-grade dysplasia or gastric cancer

Gastric mucosal brushing

Intervention Type DIAGNOSTIC_TEST

Gastric mucosal brushing will be performed at body of stomach in control group and non-tumorous area of body in gastric cancer group. If gastric body area could not feasible (eg. tumor involvement), then gastric antrum and more proximal part of body will be sampling.

Gastric mucosal biopsy

Intervention Type DIAGNOSTIC_TEST

Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.

Interventions

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Gastric mucosal brushing

Gastric mucosal brushing will be performed at body of stomach in control group and non-tumorous area of body in gastric cancer group. If gastric body area could not feasible (eg. tumor involvement), then gastric antrum and more proximal part of body will be sampling.

Intervention Type DIAGNOSTIC_TEST

Gastric mucosal biopsy

Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy (EGD)
* Gastric cancer group: patients with pathological diagnosis of high-grade dysplasia or gastric cancer
* Control group: patients with no or minimal upper GI symptoms and current EGD appear normal or minimal gastritis
* Informed consent obtained

Exclusion Criteria

* Had a history of GI or hepatobiliary surgery
* Had a history of recent (within 4 weeks) antibiotic or probiotic use
* Had a history of PPI use within 2 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rapat Pittayanon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status RECRUITING

King Chulalongkorn memorial hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thanrada Vimonsuntirungsri, MD

Role: CONTACT

+66853356240

Facility Contacts

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Rapat Pittayanon, MD

Role: primary

+66813132112

Thanrada Vimonsuntirungsri

Role: backup

+66853356240

Thanrada Vimonsuntirungsri, MD

Role: primary

+66853356240

Other Identifiers

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RP025

Identifier Type: -

Identifier Source: org_study_id

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