Gastric CancerNCT06325891
Microbiota in Gastric Cancer by Gastric Mucosal Brushing
An observational study of Gastric Cancer, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Gastric mucosal brushing and Gastric mucosal biopsy
- How many people
- 40 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Feb 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rapat Pittayanon, MD, +66813132112, rapat125@gmail.com
Thanrada Vimonsuntirungsri, +66853356240, aa_choc@docchula.com
- Recruiting
King Chulalongkorn memorial hospital
Bangkok, 10330
Thanrada Vimonsuntirungsri, MD, +66853356240, aa_choc@docchula.com
About this study
Official title: 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.
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.
- Conditions
- Gastric Cancer
- Being tested
- Gastric mucosal brushing, Gastric mucosal biopsy
- Keywords
- Microbiota, Gastric cancer, Mucosal brushing, Mucosal biopsy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Gastric mucosal biopsyDiagnostic test
Gastric mucosal biopsy will be performed at the area within 2 cm. from brushing site.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer group | * Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy
* Patients with pathological diagnosis of high-grade dysplasia or gastric cancer Receives: 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 Receives: Diagnostic Test: Gastric mucosal brushing; Diagnostic Test: Gastric mucosal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through study completion, estimate 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Feb 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325891
- Sponsor's protocol ID
- RP025
- Status last verified
- May 2024
- First submitted
- 16 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Diversity and Composition in Gastric Cancer by Gastric Mucosal Brushing: a Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT06325891
- Acronym / sponsor ID
- RP025
- Conditions
- Gastric Cancer
- Keywords
- Microbiota, Gastric cancer, Mucosal brushing, Mucosal biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer group | – | Diagnostic Test: Gastric mucosal brushing, Diagnostic Test: Gastric mucosal biopsy* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy * Patients with pathological diagnosis of high-grade dysplasia or gastric cancer |
| Control group | – | Diagnostic Test: Gastric mucosal brushing, Diagnostic Test: Gastric mucosal biopsy* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric mucosal brushingGastric 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 test | Control group, Gastric cancer group |
| Gastric mucosal biopsyGastric mucosal biopsy will be performed at the area within 2 cm. from brushing site. | Diagnostic test | Control group, Gastric cancer group |
Primary outcome
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.
1 secondary outcome
Microbiome analysis using gastric mucosal biopsy
Time frame: Through study completion, estimate 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanrada Vimonsuntirungsri, MD (+66853356240, aa_choc@docchula.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome analysis using gastric mucosal brushing (time frame: Through study completion, estimated 1.5 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.