AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

NCT06709209 | Recruiting

• 1 other identifier: APC193
• Study Type: observational
• Target: 300
• Locations: 6 countries
• Sites: 11

Brief 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). 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.

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis; Virtual Chromoendoscopy; Artificial Intelligence; Disease Assessment; Outcome Prediction

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the new scoring system

  To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity

  6 months

Secondary Outcomes (2)

• Correlation with existing score

  2 years

• AI development

  2 years

Study Arms (1)

Ulcerative Colitis patients

UC patients who have been scheduled for colonoscopy for disease assessment or surveillance

Procedure: Colonoscopy after bowel cleansing; Procedure: Intestinal biopsies; Diagnostic Test: blood sampling; Diagnostic Test: Stool; Other: Clinical follow-up

Interventions

Colonoscopy after bowel cleansing PROCEDURE

Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.

Ulcerative Colitis patients

Intestinal biopsies PROCEDURE

During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC

Ulcerative Colitis patients

blood sampling DIAGNOSTIC_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.

Ulcerative Colitis patients

Stool DIAGNOSTIC_TEST

The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.

Ulcerative Colitis patients

Clinical follow-up OTHER

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.

Ulcerative Colitis patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead
• Olympus: collaborator

Study Sites (11)

University of Leuven

Leuven, Belgium

NOT YET RECRUITING

Klinikum Luneburg

Lüneburg, Germany

NOT YET RECRUITING

University College Cork

Cork, Co Cork, Ireland

RECRUITING

Ospedale S. Maria del Prato

Feltre, Belluno, Italy

NOT YET RECRUITING

University of Bari

Bari, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Milan, Italy

NOT YET RECRUITING

University Vita-Salute San Raffaele

Milan, Italy

NOT YET RECRUITING

University of Naples

Naples, Italy

RECRUITING

University of Pavia

Pavia, Italy

NOT YET RECRUITING

Showa University

Tokyo, Japan

NOT YET RECRUITING

Changi General Hospital

Singapore, Singapore

NOT YET RECRUITING

Related Publications (10)

• 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.

  PMID: 36279923 BACKGROUND

• Iacucci 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.

  PMID: 36228649 BACKGROUND

• Hashimoto 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.

  PMID: 36627537 BACKGROUND

• Iacucci 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.

  PMID: 33347880 BACKGROUND

• Sasanuma 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.

  PMID: 29713677 BACKGROUND

• He 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.

  PMID: 35847771 BACKGROUND

• Hayashi 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.

  PMID: 36460084 BACKGROUND

• Neumann 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.

  PMID: 23839228 BACKGROUND

• Pabla 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.

  PMID: 33121688 BACKGROUND

• Katsanos 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.

  PMID: 28964677 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Intestinal biopsies, Stool

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Marietta Iacucci, MD

  University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle O'Riordan

CONTACT

+353 (0)21 4901759; moriordan@ucc.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); DE (1); IE (1); IT (6); SG (1); BE (1)