Ulcerative ColitisCUDISIANCT05171634
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)
A study testing DiscoveryTM and iSCAN in people with Ulcerative Colitis and Dysplasia, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Dysplasia
- What is being tested?
- DiscoveryTM and iSCAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2021to 18 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative Colitis confirmed by endoscopy and histology.
- Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
- Duration of the disease >7 years (or any duration if concomitant with PSC).
Who cannot join
- Personal history of colorectal cancer or high-grade dysplasia.
- Previous colectomy (partial or complete).
- Coagulopathy that prevents biopsies or polypectomy.
- Colonoscopy performed in the previous 6 months.
- Pregnant or nursing women.
- Inadequate bowel preparation.
- Presence of endoscopic Ulcerative Colitis activity.
- Colonic stenosis and incomplete colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.
- Conditions
- Ulcerative Colitis, Dysplasia
- Being tested
- DiscoveryTM, iSCAN
- Keywords
- Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscoveryTMDevice
Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).
iSCANDevice
Virtual colonoscopy assisted by iSCAN
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy assisted by DiscoveryTM | Experimental | Not described Receives: Device: DiscoveryTM |
| Virtual Colonoscopy with iSCAN | Active comparator | Not described Receives: Device: iSCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Per lesion" dysplasia detection rate (DDR)
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
Measured: Immediately after the procedure.
"Per patient" dysplasia detection rate (DDR)
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 May 2021
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Antonio López-Serrano, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171634
- Sponsor's protocol ID
- CEIm: 62.21
- Acronym
- CUDISIA
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.
PubMed 38740327
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
- ClinicalTrials.gov ID
- NCT05171634
- Acronym / sponsor ID
- CUDISIA / CEIm: 62.21
- Conditions
- Ulcerative Colitis, Dysplasia
- Keywords
- Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 5 May 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 29 Dec 2021 (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.
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy assisted by DiscoveryTM | Experimental | Device: DiscoveryTM |
| Virtual Colonoscopy with iSCAN | Active comparator | Device: iSCAN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ulcerative Colitis confirmed by endoscopy and histology.
- Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
- Duration of the disease >7 years (or any duration if concomitant with PSC).
Key exclusion criteria (8 listed)
- Personal history of colorectal cancer or high-grade dysplasia.
- Previous colectomy (partial or complete).
- Coagulopathy that prevents biopsies or polypectomy.
- Colonoscopy performed in the previous 6 months.
- Pregnant or nursing women.
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 |
|---|---|---|
| DiscoveryTMColonoscopy assisted by an artificial intelligence system (DiscoveryTM). | Device | Colonoscopy assisted by DiscoveryTM |
| iSCANVirtual colonoscopy assisted by iSCAN | Device | Virtual Colonoscopy with iSCAN |
Primary outcome
"Per lesion" dysplasia detection rate (DDR)
Time frame: Immediately after the procedure.
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
"Per patient" dysplasia detection rate (DDR)
Time frame: Immediately after the procedure.
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Results publication: PubMed 38740327Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiscoveryTM and iSCAN in people with Ulcerative Colitis and Dysplasia, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Per lesion" dysplasia detection rate (DDR) (time frame: Immediately after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171634, which also lists 1 linked publication.
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 11 Jun 2024.