NCT06325891

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

March 16, 2024

Last Update Submit

May 6, 2024

Conditions

Gastric Cancer

Keywords

MicrobiotaGastric cancerMucosal brushingMucosal biopsy

Outcome Measures

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.

    Through study completion, estimated 1.5 yr

Secondary Outcomes (1)

  • Microbiome analysis using gastric mucosal biopsy

    Through study completion, estimate 1.5 years

Study Arms (2)

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 brushingDiagnostic 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 brushingDiagnostic Test: Gastric mucosal biopsy

Interventions

Gastric mucosal brushingDIAGNOSTIC_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.

Control groupGastric cancer group
Gastric mucosal biopsyDIAGNOSTIC_TEST

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

Control groupGastric cancer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

King Chulalongkorn memorial hospital

Bangkok, 10330, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosa by gastric mucosal brushing and gastric mucosal biopsy

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Thanrada Vimonsuntirungsri, MD

CONTACT

+66853356240aa_choc@docchula.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

February 1, 2024

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

TH(2)