Atrophic Gastritis Predicts the Risk of Gastric Cancer | NCT06203327

Studies
Atrophic Gastritis Predicts the Risk of Gastric Cancer

NCT06203327

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Recruiting

Last Update Posted

Dec 30, 2024Actual

Enrollment

2,042Estimated

Phase

Not provided

Conditions

Atrophic Gastritis

Interventions

Esophagogastroscopy (OLGA 0-Ⅰ)
Esophagogastroscopy (OLGA II)
Esophagogastroscopy (OLGA III-IV)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2023Actual

Primary Completion Date

Dec 31, 2034Estimated

Completion Date

Dec 31, 2034Estimated

First Submitted Date

Dec 25, 2023

First Submission Date that Met QC Criteria

Jan 11, 2024

First Posted Date

Jan 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2024

Last Update Posted Date

Dec 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, RenJi HospitalPrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,042Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OLGA 0-I			Other: Esophagogastroscopy (OLGA 0-Ⅰ)
OLGA II			Other: Esophagogastroscopy (OLGA II)
OLGA III-IV			Other: Esophagogastroscopy (OLGA III-IV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esophagogastroscopy (OLGA 0-Ⅰ)	Other	Surveillance endoscopies at years 3-5.	OLGA 0-I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic gastritis diagnosed by routine endoscopic screening

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005757	Gastritis, Atrophic
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005756	Gastritis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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