---
title: Atrophic Gastritis and OLGIM Stage
nct_id: NCT06585553
overall_status: COMPLETED
sponsor: Shandong University
study_type: OBSERVATIONAL
primary_condition: Intestinal Metaplasia
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06585553.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06585553"
ct_last_update_post_date: 2024-09-05
last_seen_at: "2026-05-12T07:11:14.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Atrophic Gastritis and OLGIM Stage

**Official Title:** Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort

**NCT ID:** [NCT06585553](https://clinicaltrials.gov/study/NCT06585553)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 2121
- **Lead Sponsor:** Shandong University
- **Conditions:** Intestinal Metaplasia
- **Start Date:** 2022-07-01
- **Completion Date:** 2024-08-25
- **CT.gov Last Update:** 2024-09-05

## Brief 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. 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy

Exclusion Criteria:

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.
```

## Arms

- **atrophic gastritis** — Perform Kimura-Takemoto and OLGIM staging

## Primary Outcomes

- **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.

## Locations (1)

- Qilu Hospital, Jinan, Shandong, China

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.qilu hospital|jinan|shandong|china` — added _(2026-05-12)_

---

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