INCREASE: Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
Sponsor
Clinical Hospital Colentina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05744596
Collaborator
(none)
400
12
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis
Anticipated Study Start Date
:
Mar 1, 2023
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Mar 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Incisura biopsy + this arm has the incisura biopsy scored and added in the OLGA final stage |
Other: 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 |
Outcome Measures
Primary Outcome Measures
- prevalence of OLGA III-IV [at time of enrollment]
Secondary Outcome Measures
- prevalence of OLGIM III-IV [at time of enrollment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- indication to perform upper GI endoscopy for diagnosis or surveillance
Exclusion Criteria:
- lack of informed consent, gastric cancer, incomplete endoscopy, surgically altered stomach
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Clinical Hospital Colentina
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Andrei Voiosu,
Principal investigator,
Clinical Hospital Colentina
ClinicalTrials.gov Identifier:
NCT05744596
Other Study ID Numbers:
- 5/9.2.2023
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: