Ulcerative Colitis (UC)MONETNCT06709209
AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by University College Cork at 11 sites in 6 countries.
Trial summary
This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Colonoscopy after bowel cleansing, Intestinal biopsies and blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 4 Nov 2024to 30 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females between 18 and 75 years old with an established diagnosis of UC, who have undergone colonoscopy for disease assessment and surveillance will be consecutively recruited after obtaining written consent. The sample size in 300.
Who may be able to join
- Adult patients aged 18 to 75 years old
- Established diagnosis of UC (for at least six months in duration), independently from their active treatment
- Undergoing endoscopy for disease activity assessment or cancer surveillance.
Who cannot join
- Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
- Poor bowel preparation (defined as total BBPS <6 or BBPS <2 in observed segment for sigmoidoscopy)
- Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
- Pregnant and breast-feeding subjects
- Inability to provide informed consent
- If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 6 countries
Italy6 sites, 6 recruiting
- Not yet recruiting
University of Bari
Bari
Mariabeatrice Principi, b.principi@gmail.com
Mariabeatrice Principi
- Not yet recruiting
Ospedale S. Maria del Prato
Feltre, Belluno
Andrea Buda, andreabuda66@gmail.com
Andrea Buda
- Not yet recruiting
Istituto Clinico Humanitas
Milan
Alessandro Armuzzi, alessandro.armuzzi@hunimed.eu
Alessandro Armuzzi
- Not yet recruiting
University Vita-Salute San Raffaele
Milan
Silvio Danese, danese.silvio@hsr.it
Silvio Danese
- Recruiting
University of Naples
Naples
Olga Maria Nardone, olgamaria.nardone@unina.it
Olga Maria Nardone
- Not yet recruiting
University of Pavia
Pavia
Antonio Di Sabatino, A.DiSabatino@smatteo.pv.it
Antonio Di Sabatino
Belgium1 site, 1 recruiting
- Not yet recruiting
University of Leuven
Leuven
Raf Bisschops, raf.bisschops@uzleuven.be
Raf Bisschops
Germany1 site, 1 recruiting
- Not yet recruiting
Klinikum Luneburg
Lüneburg
Torsten Kucharzik, Torsten.Kucharzik@klinikum-lueneburg.de
Torsten Kucharzik
Ireland1 site, 1 recruiting
- Recruiting
University College Cork
Cork, Co Cork
Michelle O'Riordan, +353 (0)21 4901759, moriordan@ucc.ie
Marietta Iacucci
Japan1 site, 1 recruiting
- Not yet recruiting
Showa University
Tokyo
Yasuharu Maeda, yasuharumaeda610@hotmail.com
Yasuharu Maeda
Singapore1 site, 1 recruiting
- Not yet recruiting
Changi General Hospital
Singapore
Kimg Tan Chin, ckimg87@yahoo.com
Kimg Tan Chin
About this study
Official title: A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study
This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.
Read the detailed description
This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes.
The study will be divided in several phases:
- In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive.
- In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated
- In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module.
- In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Colonoscopy after bowel cleansing, Intestinal biopsies, blood sampling, Stool, Clinical follow-up
- Keywords
- Ulcerative Colitis, Virtual Chromoendoscopy, Artificial Intelligence, Disease Assessment, Outcome Prediction
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy after bowel cleansingProcedure or surgery
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.
Intestinal biopsiesProcedure or surgery
During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC
blood samplingDiagnostic test
Blood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research.
StoolDiagnostic test
The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.
Clinical follow-upOther
Patients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis patients | UC patients who have been scheduled for colonoscopy for disease assessment or surveillance Receives: Procedure: Colonoscopy after bowel cleansing; Procedure: Intestinal biopsies; Diagnostic Test: blood sampling; Diagnostic Test: Stool; Other: Clinical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the new scoring system
To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity
Measured: 6 months
Secondary outcomes (2)
Correlation with existing score
To evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes
Measured: 2 years
AI development
Develop and adapt existing AI algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes in UC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start4 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Marietta Iacucci, MD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709209
- Sponsor's protocol ID
- APC193
- Acronym
- MONET
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
PubMed 36279923Iacucci M, Cannatelli R, Parigi TL, Nardone OM, Tontini GE, Labarile N, Buda A, Rimondi A, Bazarova A, Bisschops R, Del Amor R, Meseguer P, Naranjo V, Ghosh S, Grisan E; PICaSSO group. A virtual chromoendoscopy artificial intelligence system to detect endoscopic and histologic activity/remission and predict clinical outcomes in ulcerative colitis. Endoscopy. 2023 Apr;55(4):332-341. doi: 10.1055/a-1960-3645. Epub 2022 Oct 13.
PubMed 36228649Hashimoto Y, Kuribayashi S, Sato K, Itoi Y, Nakata K, Kasuga K, Tanaka H, Hosaka H, Ikota H, Iacucci M, Uraoka T. Validation of red dichromatic imaging score (RDI score) to evaluate the severity of ulcerative colitis. Surg Endosc. 2023 May;37(5):3627-3633. doi: 10.1007/s00464-022-09852-0. Epub 2023 Jan 10.
PubMed 36627537Iacucci M, Smith SCL, Bazarova A, Shivaji UN, Bhandari P, Cannatelli R, Daperno M, Ferraz J, Goetz M, Gui X, Hayee B, De Hertogh G, Lazarev M, Li J, Nardone OM, Parra-Blanco A, Pastorelli L, Panaccione R, Occhipinti V, Rath T, Tontini GE, Vieth M, Villanacci V, Zardo D, Bisschops R, Kiesslich R, Ghosh S. An International Multicenter Real-Life Prospective Study of Electronic Chromoendoscopy Score PICaSSO in Ulcerative Colitis. Gastroenterology. 2021 Apr;160(5):1558-1569.e8. doi: 10.1053/j.gastro.2020.12.024. Epub 2021 Feb 6.
PubMed 33347880Sasanuma S, Ohtsuka K, Kudo SE, Ogata N, Maeda Y, Misawa M, Mori Y, Kudo T, Hisayuki T, Wakamura K, Hayashi T, Katagiri A, Miyachi H, Baba T, Ishida F. Narrow band imaging efficiency in evaluation of mucosal healing/relapse of ulcerative colitis. Endosc Int Open. 2018 May;6(5):E518-E523. doi: 10.1055/s-0044-102297. Epub 2018 Apr 18.
PubMed 29713677He T, Zong L, Pan P, Sun S, Qu H. Predicting Histological Healing and Recurrence in Ulcerative Colitis by Assessing Mucosal Vascular Pattern Under Narrow-Band Imaging Endoscopy. Front Med (Lausanne). 2022 Jun 30;9:869981. doi: 10.3389/fmed.2022.869981. eCollection 2022.
PubMed 35847771Hayashi Y, Takabayashi K, Kato M, Tojo A, Aoki Y, Hagihara Y, Yoshida K, Yoshimatsu Y, Kiyohara H, Sugimoto S, Nanki K, Mikami Y, Sujino T, Mutaguchi M, Kawaguchi T, Hosoe N, Yahagi N, Ogata H, Kanai T. Usefulness of texture and color enhancement imaging in assessing mucosal healing in patients with ulcerative colitis. Gastrointest Endosc. 2023 Apr;97(4):759-766.e1. doi: 10.1016/j.gie.2022.11.019. Epub 2022 Nov 30.
PubMed 36460084Neumann H, Vieth M, Gunther C, Neufert C, Kiesslich R, Grauer M, Atreya R, Neurath MF. Virtual chromoendoscopy for prediction of severity and disease extent in patients with inflammatory bowel disease: a randomized controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1935-42. doi: 10.1097/MIB.0b013e318290550e.
PubMed 23839228Pabla BS, Schwartz DA. Assessing Severity of Disease in Patients with Ulcerative Colitis. Gastroenterol Clin North Am. 2020 Dec;49(4):671-688. doi: 10.1016/j.gtc.2020.08.003. Epub 2020 Sep 23.
PubMed 33121688Katsanos KH, Papamichael K, Christodoulou DK, Cheifetz AS. Histological healing beyond endoscopic healing in ulcerative colitis: Shall we target the "ultra-deep" remission? Dig Liver Dis. 2017 Dec;49(12):1332-1333. doi: 10.1016/j.dld.2017.08.043. Epub 2017 Sep 18. No abstract available.
PubMed 28964677
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study
- ClinicalTrials.gov ID
- NCT06709209
- Acronym / sponsor ID
- MONET / APC193
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, Virtual Chromoendoscopy, Artificial Intelligence, Disease Assessment, Outcome Prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Nov 2024 (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 international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.
Detailed description
This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes.
The study will be divided in several phases:
- In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive.
- In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated
- In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module.
- In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis patients | – | Procedure: Colonoscopy after bowel cleansing, Procedure: Intestinal biopsies, Diagnostic Test: blood sampling, Diagnostic Test: Stool, Other: Clinical follow-upUC patients who have been scheduled for colonoscopy for disease assessment or surveillance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females between 18 and 75 years old with an established diagnosis of UC, who have undergone colonoscopy for disease assessment and surveillance will be consecutively recruited after obtaining written consent. The sample size in 300.
Key inclusion criteria (3 listed)
- Adult patients aged 18 to 75 years old
- Established diagnosis of UC (for at least six months in duration), independently from their active treatment
- Undergoing endoscopy for disease activity assessment or cancer surveillance.
Key exclusion criteria (6 listed)
- Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
- Poor bowel preparation (defined as total BBPS <6 or BBPS <2 in observed segment for sigmoidoscopy)
- Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
- Pregnant and breast-feeding subjects
- Inability to provide informed consent
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 |
|---|---|---|
| Colonoscopy after bowel cleansingColonoscopy will be performed using HD-WLE; TXI; RDI and NBI. | Procedure or surgery | Ulcerative Colitis patients |
| Intestinal biopsiesDuring colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC | Procedure or surgery | Ulcerative Colitis patients |
| blood samplingBlood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research. | Diagnostic test | Ulcerative Colitis patients |
| StoolThe stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity. | Diagnostic test | Ulcerative Colitis patients |
| Clinical follow-upPatients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated. | Other | Ulcerative Colitis patients |
Primary outcome
Diagnostic performance of the new scoring system
Time frame: 6 months
To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity
2 secondary outcomes
Correlation with existing score
Time frame: 2 years
AI development
Time frame: 2 years
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 3 Dec 2024.
- Background: PubMed 36279923Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
- Background: PubMed 36228649Iacucci M, Cannatelli R, Parigi TL, Nardone OM, Tontini GE, Labarile N, Buda A, Rimondi A, Bazarova A, Bisschops R, Del Amor R, Meseguer P, Naranjo V, Ghosh S, Grisan E; PICaSSO group. A virtual chromoendoscopy artificial intelligence system to detect endoscopic and histologic activity/remission and predict clinical outcomes in ulcerative colitis. Endoscopy. 2023 Apr;55(4):332-341. doi: 10.1055/a-1960-3645. Epub 2022 Oct 13.
- Background: PubMed 36627537Hashimoto Y, Kuribayashi S, Sato K, Itoi Y, Nakata K, Kasuga K, Tanaka H, Hosaka H, Ikota H, Iacucci M, Uraoka T. Validation of red dichromatic imaging score (RDI score) to evaluate the severity of ulcerative colitis. Surg Endosc. 2023 May;37(5):3627-3633. doi: 10.1007/s00464-022-09852-0. Epub 2023 Jan 10.
- Background: PubMed 33347880Iacucci M, Smith SCL, Bazarova A, Shivaji UN, Bhandari P, Cannatelli R, Daperno M, Ferraz J, Goetz M, Gui X, Hayee B, De Hertogh G, Lazarev M, Li J, Nardone OM, Parra-Blanco A, Pastorelli L, Panaccione R, Occhipinti V, Rath T, Tontini GE, Vieth M, Villanacci V, Zardo D, Bisschops R, Kiesslich R, Ghosh S. An International Multicenter Real-Life Prospective Study of Electronic Chromoendoscopy Score PICaSSO in Ulcerative Colitis. Gastroenterology. 2021 Apr;160(5):1558-1569.e8. doi: 10.1053/j.gastro.2020.12.024. Epub 2021 Feb 6.
- Background: PubMed 29713677Sasanuma S, Ohtsuka K, Kudo SE, Ogata N, Maeda Y, Misawa M, Mori Y, Kudo T, Hisayuki T, Wakamura K, Hayashi T, Katagiri A, Miyachi H, Baba T, Ishida F. Narrow band imaging efficiency in evaluation of mucosal healing/relapse of ulcerative colitis. Endosc Int Open. 2018 May;6(5):E518-E523. doi: 10.1055/s-0044-102297. Epub 2018 Apr 18.
- Background: PubMed 35847771He T, Zong L, Pan P, Sun S, Qu H. Predicting Histological Healing and Recurrence in Ulcerative Colitis by Assessing Mucosal Vascular Pattern Under Narrow-Band Imaging Endoscopy. Front Med (Lausanne). 2022 Jun 30;9:869981. doi: 10.3389/fmed.2022.869981. eCollection 2022.
- Background: PubMed 36460084Hayashi Y, Takabayashi K, Kato M, Tojo A, Aoki Y, Hagihara Y, Yoshida K, Yoshimatsu Y, Kiyohara H, Sugimoto S, Nanki K, Mikami Y, Sujino T, Mutaguchi M, Kawaguchi T, Hosoe N, Yahagi N, Ogata H, Kanai T. Usefulness of texture and color enhancement imaging in assessing mucosal healing in patients with ulcerative colitis. Gastrointest Endosc. 2023 Apr;97(4):759-766.e1. doi: 10.1016/j.gie.2022.11.019. Epub 2022 Nov 30.
- Background: PubMed 23839228Neumann H, Vieth M, Gunther C, Neufert C, Kiesslich R, Grauer M, Atreya R, Neurath MF. Virtual chromoendoscopy for prediction of severity and disease extent in patients with inflammatory bowel disease: a randomized controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1935-42. doi: 10.1097/MIB.0b013e318290550e.
- Background: PubMed 33121688Pabla BS, Schwartz DA. Assessing Severity of Disease in Patients with Ulcerative Colitis. Gastroenterol Clin North Am. 2020 Dec;49(4):671-688. doi: 10.1016/j.gtc.2020.08.003. Epub 2020 Sep 23.
- Background: PubMed 28964677Katsanos KH, Papamichael K, Christodoulou DK, Cheifetz AS. Histological healing beyond endoscopic healing in ulcerative colitis: Shall we target the "ultra-deep" remission? Dig Liver Dis. 2017 Dec;49(12):1332-1333. doi: 10.1016/j.dld.2017.08.043. Epub 2017 Sep 18. No abstract available.
- 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.
Marietta Iacucci, MD principal investigator
University College Cork
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by University College Cork at 11 sites in 6 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 3 inclusion and 6 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Belgium, Germany, Ireland, Japan and 1 more country. 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 Michelle O'Riordan (+353 (0)21 4901759, moriordan@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the new scoring system (time frame: 6 months). 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 NCT06709209, which also lists 10 linked publications.
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 3 Dec 2024.