Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
NCT ID: NCT05744596
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-03-23
2027-03-31
Brief Summary
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Detailed Description
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In designing the study, we opted for a non-inferiority paired design with high-risk chronic gastritis as a primary binary outcome and a non-inferiority margin (Δ) of 5 % (two-sided 95% CI). The non-inferiority margin was established according to clinical judgement, taking into consideration the significance of a missed diagnosis of high-risk preneoplastic condition and previous estimates of the added value offered by the added incisura biopsy. With a power of 80% and a 2-sided α-level set at 0.05, we estimate that 370 subjects are needed to show non-inferiority. Finally, we will enroll 400 subjects to compensate for eventual exclusions or protocol deviations.
Cohen's kappa will be used to rate intra and inter-observer concordance for pathologists.
An intermediary analysis for futility is scheduled after 100 patients (25%) are enrolled.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Incisura biopsy +
this arm has the incisura biopsy scored and added in the OLGA final stage
Incisura biopsy analysis
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Incisura biopsy -
this arm only has corpus and antrum biopsies scored for OLGA staging
No interventions assigned to this group
Interventions
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Incisura biopsy analysis
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Clinical Hospital Colentina
OTHER
Responsible Party
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Andrei Voiosu
Principal investigator
Locations
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Colentina Clinical Hospital
Bucharest, Bucharest, Romania
Countries
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Central Contacts
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Facility Contacts
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Andrei Voiosu, PhD
Role: primary
Other Identifiers
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INCREASE
Identifier Type: -
Identifier Source: org_study_id
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