NCT06203327

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,042

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Dec 2023Dec 2034

Study Start

First participant enrolled

December 15, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

December 30, 2024

Status Verified

December 1, 2023

Enrollment Period

11.1 years

First QC Date

December 25, 2023

Last Update Submit

December 26, 2024

Conditions

Keywords

Atrophic GastritisGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.

Study Arms (3)

OLGA 0-I

Other: Esophagogastroscopy (OLGA 0-Ⅰ)

OLGA II

Other: Esophagogastroscopy (OLGA II)

OLGA III-IV

Other: Esophagogastroscopy (OLGA III-IV)

Interventions

Surveillance endoscopies at years 3-5.

OLGA 0-I

Surveillance endoscopies at years 2-3.

OLGA II

Surveillance endoscopies every year.

OLGA III-IV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic gastritis diagnosed by routine endoscopic screening

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Gastritis, AtrophicStomach Neoplasms

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 12, 2024

Study Start

December 15, 2023

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Last Updated

December 30, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations