Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
INCREASE
Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis
1 other identifier
observational
400
2 countries
2
Brief Summary
This prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (OLGA stages III-IV). It compares a biopsy protocol with and without a single incisura biopsy in a non-inferiority design. Anonymized photo and videodocumentation according to institution practices will constitute a databank for lesion recognition, quality improvement, and potential AI development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
2 active sites
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
First Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
March 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 9, 2026
January 1, 2026
3.7 years
February 7, 2023
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
prevalence of OLGA III-IV
number of patients with confirmed OLGA III-IV
at time of enrollment
Secondary Outcomes (1)
prevalence of OLGIM III-IV
at time of enrollment
Study Arms (2)
Incisura biopsy +
this arm has the incisura biopsy scored and added in the OLGA final stage
Incisura biopsy -
this arm only has corpus and antrum biopsies scored for OLGA staging
Interventions
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Eligibility Criteria
All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.
You may qualify if:
- indication to perform upper GI endoscopy for diagnosis or surveillance
You may not qualify if:
- lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IPO Porto
Porto, Portugal
Colentina Clinical Hospital
Bucharest, Bucharest, 021025, Romania
Biospecimen
gastric mucosa biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 27, 2023
Study Start
March 23, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- The data will be available during the study period, after enrollment of all participants. Possible usage of the anonymized database will be discussed by study investigators.
- Access Criteria
- reasonable request
Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.