Chronic; Gastritis, AtrophicINCREASENCT05744596
Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
An observational study of Chronic; Gastritis, Atrophic, run by Clinical Hospital Colentina at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic; Gastritis, Atrophic
- What is being tested?
- Incisura biopsy analysis
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Mar 2023to Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.
Who may be able to join
- indication to perform upper GI endoscopy for diagnosis or surveillance
Who cannot join
- lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Romania1 site, 1 recruiting
- Recruiting
Colentina Clinical Hospital
Bucharest, Bucharest, 021025
Andrei Voiosu, PhD, +4 021 3173245
Andrei Voiosu, PhD
About this study
Official title: 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. Anonymized photo and videodocumentation according to institution practices will constitute a databank for lesion recognition, quality improvement, and potential AI development.
Read the detailed description
The investigators will perform a prospective, multicenter, randomized controlled trial of 2 different gastric biopsy protocols. The hypothesis is that a gastric mapping protocol not including the incisura biopsy ("I-": 2 biopsies from the antrum, 2 from the corpus) is non-inferior to the conventional 5-biopsy approach ("I+": 2 biopsies from the antrum, 2 from the corpus, 1 from the incisura). The primary endpoint of this study is to assess the sensitivity of the "I-" protocol in diagnosing high-risk precancerous chronic gastritis (OLGA/OLGIM stages III or IV) compared to the assumed gold standard of histology based on the "I+" protocol.
In designing the study, the investigators 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, it is estimated that 370 subjects are needed to show non-inferiority. Finally, 400 subjects will be enrolled 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
- Chronic; Gastritis, Atrophic
- Being tested
- Incisura biopsy analysis
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisura biopsy analysisOther
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
| Study group | Role | What they receive |
|---|---|---|
| Incisura biopsy + | this arm has the incisura biopsy scored and added in the OLGA final stage Receives: Other: Incisura biopsy analysis | |
| Incisura biopsy - | this arm only has corpus and antrum biopsies scored for OLGA staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of OLGA III-IV
number of patients with confirmed OLGA III-IV
Measured: at time of enrollment
Secondary outcomes (1)
prevalence of OLGIM III-IV
number of patients with confirmed OLGIM III-IV
Measured: at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start23 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic; Gastritis, AtrophicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Responsible party
- Principal investigator, Andrei Voiosu, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744596
- Sponsor's protocol ID
- INCREASE
- Acronym
- INCREASE
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.