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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis
- ClinicalTrials.gov ID
- NCT05744596
- Acronym / sponsor ID
- INCREASE / INCREASE
- Conditions
- Chronic; Gastritis, Atrophic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Collaborators
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incisura biopsy + | – | Other: Incisura biopsy analysisthis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- indication to perform upper GI endoscopy for diagnosis or surveillance
Key exclusion criteria (1 listed)
- lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incisura biopsy analysisa pathologist blinded to the other biopsies analyzes the biopsy from the incisura | Other | Incisura biopsy + |
Primary outcome
prevalence of OLGA III-IV
Time frame: at time of enrollment
number of patients with confirmed OLGA III-IV
1 secondary outcome
prevalence of OLGIM III-IV
Time frame: at time of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic; Gastritis, Atrophic, run by Clinical Hospital Colentina at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrei Voiosu (+40213173245, andreivoiosu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of OLGA III-IV (time frame: at time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.