ClinicalTrials.gg
RecruitingNCT06325891Updated May 7, 2024

Microbiota in Gastric Cancer by Gastric Mucosal Brushing

An observational study in Gastric Cancer, sponsored by King Chulalongkorn Memorial Hospital. Recruiting at 2 sites in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by King Chulalongkorn Memorial Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 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.
02

Conditions studied

  • Gastric Cancer

Browse trials for

Keywords

  • Microbiota
  • Gastric cancer
  • Mucosal brushing
  • Mucosal biopsy
03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 40 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 43 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  • 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • obtained

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Gastric cancer group

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

    Diagnostic Test: Gastric mucosal brushing · Diagnostic Test: Gastric mucosal biopsy

  • 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

    Diagnostic Test: Gastric mucosal brushing · Diagnostic Test: Gastric mucosal biopsy

Interventions

  • Diagnostic testGastric 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.

  • Diagnostic testGastric mucosal biopsy

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

06

What researchers measure

Primary outcomes

  1. Microbiome analysis using gastric mucosal brushing

    Gastric mucosal-associated microbiota in patients with gastric cancer and those without gastric cancer using mucosal brush sampling by 16S rRNA sequencing. Including microbiota diversity and composition.

    Time frame: Through study completion, estimated 1.5 yr

Secondary outcomes

  1. Microbiome analysis using gastric mucosal biopsy

    Gastric mucosal-associated microbiota between samples obtained from gastric mucosal tissue biopsy and mucosal brushing in patients with gastric cancer and those without gastric cancer

    Time frame: Through study completion, estimate 1.5 years

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for Mar 2025, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2024
First posted
Mar 22, 2024
StartActual
Feb 1, 2024
Primary completionEst.
Mar 31, 2025
CompletionEst.
May 31, 2025
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06325891
Lead sponsor
King Chulalongkorn Memorial Hospital
Responsible party
Rapat Pittayanon (Associate Professor, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Mar 22, 2024
Start date
Feb 1, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
May 7, 2024

Study contacts

Thanrada Vimonsuntirungsri, MD
Contact
aa_choc@docchula.com
+66853356240

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion