Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis (INCREASE)

April 2, 2024 updated by: Andrei Voiosu, Clinical Hospital Colentina

Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Bucharest, Romania, 021025
        • Recruiting
        • Colentina Clinical Hospital
        • Contact:
          • Andrei Voiosu, PhD
          • Phone Number: +4 021 3173245
        • Principal Investigator:
          • Andrei Voiosu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.

Description

Inclusion Criteria:

  • indication to perform upper GI endoscopy for diagnosis or surveillance

Exclusion Criteria:

  • lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of OLGA III-IV
Time Frame: at time of enrollment
at time of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
prevalence of OLGIM III-IV
Time Frame: at time of enrollment
at time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Colentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCREASE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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