Microbiota in Gastric Cancer by Gastric Mucosal Brushing

May 6, 2024 updated by: Rapat Pittayanon, King Chulalongkorn Memorial Hospital

Microbiota Diversity and Composition in Gastric Cancer by Gastric Mucosal Brushing: a Cross-sectional Case-control Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 biopsy
Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.
Diagnostic test: 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.
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 biopsy
Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiome analysis using gastric mucosal brushing
Time Frame: Through study completion, estimated 1.5 yr
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiome analysis using gastric mucosal biopsy
Time Frame: Through study completion, estimate 1.5 years
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
Through study completion, estimate 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Chulalongkorn Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RP025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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