Intestinal MetaplasiaNCT06585553
Atrophic Gastritis and OLGIM Stage
An observational study of Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Intestinal Metaplasia
- How many people
- 2,121 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 25 Aug 2024
- How long will I take part?
- 3 Years
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Who may be able to join
- Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy
Who cannot join
- 1) previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort
Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.
- Conditions
- Intestinal Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| atrophic gastritis | Perform Kimura-Takemoto and OLGIM staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of IM at Different Sites
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Jul 2022
- Primary completion30 Jul 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal MetaplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,121 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585553
- Sponsor's protocol ID
- 20240904
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma M, Liu M, Liang X, Zuo X. Assessment of intestinal metaplasia at the lesser curvature guides mapping biopsies strategy. Scand J Gastroenterol. 2025 Nov;60(11):1053-1060. doi: 10.1080/00365521.2025.2561058. Epub 2025 Sep 20.
PubMed 40975786
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort
- ClinicalTrials.gov ID
- NCT06585553
- Acronym / sponsor ID
- 20240904
- Conditions
- Intestinal Metaplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,121 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 5 Sep 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.
Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrophic gastritis | – | –Perform Kimura-Takemoto and OLGIM staging |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Key inclusion criteria (1 listed)
- Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy
Key exclusion criteria (1 listed)
- 1) previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of IM at Different Sites
Time frame: 3 years
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 40975786Ma M, Liu M, Liang X, Zuo X. Assessment of intestinal metaplasia at the lesser curvature guides mapping biopsies strategy. Scand J Gastroenterol. 2025 Nov;60(11):1053-1060. doi: 10.1080/00365521.2025.2561058. Epub 2025 Sep 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Metaplasia, run by Shandong University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of IM at Different Sites (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585553, which also lists 1 linked publication.
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 5 Sep 2024.