Atrophic Gastritis Predicts the Risk of Gastric Cancer

Atrophic Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203327
• Other study ID #: rjhy20230004
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2034

Study information

• Verified date: December 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2042
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastritis
• Gastritis, Atrophic
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early gastric neoplasm	histological diagnosis of high-grade dysplasia, and adenocarcinoma.	After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-?, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.