Clinical trial · Observational
Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features
Development and Validation of a Prediction Model for Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features: a Prospective Cohort Study
NCT06853509CI-TRIAL-00086685not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, single-center, cohort study to development and validation of a prediction model for predicting gastric neoplasia in patients with high-risk endoscopic features
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High-risk endoscopic features
- description
- Patients found active Helicobacter pylori infection or atrophic gastritis in initial esophagogastroduodenoscopy.
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (1)
- measure
- Detection rate of gastric neoplasia
- timeFrame
- 2 weeks after the last follow-up
- description
- Detection rate of gastric neoplasia during follow-up. Gastric neoplasia was defined as low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and adenocarcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 45 years 2. Meets the definition of a high-risk population for gastric cancer, which includes one or more of the following: (1) Residence in a high-incidence region for gastric cancer (2) Helicobacter pylori (Hp) infection (3) History of chronic atrophic gastritis, gastric ulcer, gastric polyps, post-gastrectomy status, hypertrophic gastritis, pernicious anemia, or other precancerous gastric conditions (4) First-degree relatives of patients with gastric cancer (5) Other risk factors for gastric cancer such as high salt intake, frequent consumption of pickled foods, smoking, or heavy alcohol use 3. No gastric cancer or precancerous lesions detected on initial esophagogastroduodenoscopy, yet with endoscopic features consistent with high-risk endoscopic features. High-risk endoscopic include: (1) Active Helicobacter pylori infection (2) Atrophic gastritis (Kimura-Takemoto classification C1-O3) 4. Provision of written informed consent and agreement to comply with the follow-up requirements specified in the study protocol Exclusion Criteria: 1. Emergency esophagogastroduodenoscopy 2. History of partial or total gastrectomy 3. ASA physical status classification of 3 or higher 4. Use of oral antiplatelet or anticoagulant medications, or coagulopathy (defined as a platelet count \< 50 × 10\^9/L or INR \> 1.5) 5. Pregnancy or lactation 6. Severe cardiac, pulmonary, hepatic, or renal disease 7. Concomitant other malignant tumors or severe infectious diseases 8. Refusal to sign the informed consent form or any other condition deemed unsuitable for study participation
References
Publications (0)
Data not yet available
No reference posted for this study.