Multi-center Prospective Validation of Real-Time AI-EGGIM System
NCT07915843, Not yet recruiting, Qilu Hospital of Shandong University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multi-center Prospective Validation of Real-Time AI-EGGIM System | ClinicalTrials.gov |
| NCT number | NCT07915843 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 540 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Hospital of Shandong University | ClinicalTrials.gov |
| Conditions | Gastric Intestinal Metaplasia | ClinicalTrials.gov |
| Interventions | AI-EGGIM Assessment | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sensitivity of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer | From the endoscopy examination to completion of histopathological assessment, up to 14 days | Sensitivity will be calculated as the proportion of participants with histopathologically confirmed OLGIM stages III/IV who have an AI-EGGIM score ≥ 5: true positives divided by the sum of true positives and false negatives. | ClinicalTrials.gov |
| Secondary | Specificity, Accuracy, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer | From the endoscopy examination to completion of histopathological assessment, up to 14 days | Specificity will be calculated as the proportion of patients without histopathologically confirmed OLGIM stages III/IV who have an AI-EGGIM score \< 5: true negatives divided by the sum of true negatives and false positives. Accuracy will be calculated as the sum of true positives and true negatives divided by the total number of patients. Positive predictive value will be calculated as true positives divided by the sum of true positives and false positives. Negative predictive value will be calculated as true negatives divided by the sum of true negatives and false negatives. The area under the receiver operating characteristic curve (AUC) will be estimated using AI-EGGIM scores against OLGIM stages III/IV. | ClinicalTrials.gov |
| Secondary | Correlation and Association of AI-EGGIM Score with OLGIM Stage and Kimura-Takemoto Classification | From the endoscopy examination to completion of histopathological assessment, up to 14 days | The correlation of AI-EGGIM score (0-10) with histopathological OLGIM stage (0-IV) and with the ordered Kimura-Takemoto classification will be assessed using Spearman's rank correlation coefficient. In addition, unadjusted and adjusted odds ratios with 95% confidence intervals will be estimated for the associations of AI-EGGIM score ≥5 with OLGIM stages III/IV and with Kimura-Takemoto open-type atrophy (O1-O3). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)