Atrophic Gastritis Predicts the Risk of Gastric Cancer

NCT06203327 — Recruiting, 2042 participants, Shanghai Jiao Tong University School of Medicine

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Atrophic Gastritis Predicts the Risk of Gastric Cancer: a Prospective Cohort Study

Registry	NCT06203327
Status	Recruiting
Study type	Observational
Enrollment	2042 (Estimated)
Sponsor	Shanghai Jiao Tong University School of Medicine (Other)
Conditions	Atrophic Gastritis
Interventions	Esophagogastroscopy (OLGA 0-Ⅰ), Esophagogastroscopy (OLGA II), Esophagogastroscopy (OLGA III-IV) (Other)
Dates	start 2023-12-15, primary completion 2034-12-31 (estimated), completion 2034-12-31 (estimated), first posted 2024-01-12, last updated 2024-12-30
Locations	1 site in China

-Summary

Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.

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+Arms and interventions

Arm	Type	Interventions	Description
OLGA 0-I		Other: Esophagogastroscopy (OLGA 0-Ⅰ)
OLGA II		Other: Esophagogastroscopy (OLGA II)
OLGA III-IV		Other: Esophagogastroscopy (OLGA III-IV)

Esophagogastroscopy (OLGA 0-Ⅰ) (Other): Surveillance endoscopies at years 3-5.
Esophagogastroscopy (OLGA II) (Other): Surveillance endoscopies at years 2-3.
Esophagogastroscopy (OLGA III-IV) (Other): Surveillance endoscopies every year.

+Outcome measures

Primary outcomes

early gastric neoplasm [After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.]: histological diagnosis of high-grade dysplasia, and adenocarcinoma.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Biopsies were collected based on the recommendation of updated Sydney system

Exclusion Criteria:

* under 18 or over 80 years old
* history of gastrectomy
* severe systemic diseases or malignancy

+Locations (1)

Facility	City	Country	Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai, Shanghai Municipality	China	Recruiting