AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

NCT06505304 | Recruiting

• 1 other identifier: APC188
• Study Type: observational
• Target: 225
• Locations: 6 countries
• Sites: 15

Brief Summary

This is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.

Conditions

Crohn Disease

Keywords

Crohn's disease; Artificial Intelligence; Virtual Chromoendoscopy; Confocal laser endomicroscopy; OMIC; Machine Learning; Post-operative recurrence

Outcome Measures

Primary Outcomes (2)

• Early post-operative endoscopic recurrence

  Post surgical endoscopic recurrence will be defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \> 2 and Rutgeerts score \> i2a

  3 months or 6 months

• Early post-operative clinical recurrence

  Post surgical clinical recurrence will be defined as: * CD Activity Index score (CDAI) \>200 and a \>70-point increase from baseline, or * development of a new or re-draining fistula or abscess, or * requiring steroids, endoscopic dilatation, or hospitalization

  3 months and 6 months

Secondary Outcomes (3)

• Post-operative clinical recurrence

  1 year and 2 years

• Early post-operative histological recurrence

  3 months or 6 months

• Early post-operative IUS recurrence

  3 months or 6 months

Study Arms (1)

Post-operative CD

Patients undergoing surgery or with a previous (within 3 months from the enrolment) surgery for CD

Procedure: Colonoscopy; Procedure: Intestinal biopsies; Procedure: Confocal laser endomicroscopy; Procedure: Intestinal ultrasound; Diagnostic Test: Stool; Diagnostic Test: Blood; Diagnostic Test: Saliva; Other: Clinical follow-up

Interventions

Colonoscopy PROCEDURE

The colonoscopy will be performed at 3 or 6 months after surgery according to FC: * In patients with FCP \>=150µg/g at around 3 months after surgery, a colonoscopy will be immediately performed * In patients with FCP \<150µg/g at around 3 months after surgery, the colonoscopy will be organized at 6 months after surgery Colonoscopy will be performed using high definition white-light endoscopy (HD-WLE) followed by virtual chromoendoscopy (VCE). The neoterminal ileum, ileocolic anastomosis and right colon will be assessed. A follow-up colonoscopy will be performed within 18 months after index colonoscopy, as standard of care.

Post-operative CD

Intestinal biopsies PROCEDURE

During index colonoscopy, at least 2 biopsies from each of the segments will be taken as standard of practice to assess inflammation in post-operative CD. Only in Irish sites, twelve biopsies - four in the area of ileocolonic anastomosis, four in the neo-terminal ileum and four in the colon just distal to the anastomosis- will be taken for research purposes, in addition to standard-of-care biopsies.

Post-operative CD

Confocal laser endomicroscopy PROCEDURE

pCLE with fluorescein injection will be performed during index colonoscopy, in centres where is available, to assess early alteration of the barrier function.

Post-operative CD

Intestinal ultrasound PROCEDURE

All patients will undergo a cross-sectional imaging test as part of their standard of care at 3 and 6 months after surgery. A follow-up IUS will be performed within 18 months after index colonoscopy, as standard of care.

Post-operative CD

Stool DIAGNOSTIC_TEST

Stool samples will be collected at 3 and 6 months after surgery and used for faecal calprotectin analysis. Research stool will be collected during the visit of index colonoscopy and at 12 months after index colonoscopy for metagenomics (only in Irish sites).

Post-operative CD

Blood DIAGNOSTIC_TEST

Blood will be collected at 3 and 6 months after surgery and used as standard of care. Research blood will be collected during the visit of index colonoscopy and at 12 months after index colonoscopy for research - i.e. proteomic, genomic, cell experiments (only in Irish sites).

Post-operative CD

Saliva DIAGNOSTIC_TEST

Saliva will be collected during the visit of index colonoscopy and at 12 months after surgery for research - i.e. optical spectroscopy (only in Irish site)

Post-operative CD

Clinical follow-up OTHER

Patients will be followed-up at 6, 12 and 24 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. The following scores will be repeated: Harvey Bradshaw Index (HBI) and CD Activity Index score (CDAI). Participants will give an update on their medication use.

Post-operative CD

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 aged between 18 and 75 years old and with an established diagnosis of CD, who have undergone surgery no more than three months before study entry, or have surgery planned, will be consecutively recruited after obtaining written consent. The sample size for the study is 225

You may qualify if:

• Patients aged between 18 years and 75 years.
• Established diagnosis of CD at least six months prior to study.
• Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.

You may not qualify if:

• Inability to provide consent.
• Presence of serious co-morbidities (clinical contraindication).
• Presence of ostomy.
• Pregnancy or breastfeeding.
• Contraindication for colonoscopy or biopsies.
• Boston Bowel Preparation Scale Score \<2 in the rectum plus left-sided colon.
• Allergy to nuts or shellfish.
• Severe or uncontrolled asthma.
• Use of beta blockers.
• Previous history of reaction to fluorescein.
• Patients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.

Sponsors & Collaborators

• University College Cork: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (15)

University of Leuven

Leuven, Belgium

ACTIVE NOT RECRUITING

University of Calgary

Calgary, Canada

RECRUITING

University Hospital Erlangen

Erlangen, Germany

ACTIVE NOT RECRUITING

Cork University Hospital

Cork, Ireland

ACTIVE NOT RECRUITING

Mercy University Hospital

Cork, Ireland

ACTIVE NOT RECRUITING

University College Dublin

Dublin, Ireland

RECRUITING

University College Hospitals Galway

Galway, Ireland

ACTIVE NOT RECRUITING

Rabin Medical Centre

Tel Aviv, Israel

RECRUITING

Istituto Clinico Humanitas

Rozzano, Milan, Italy

ACTIVE NOT RECRUITING

ASST Spedali Civili

Brescia, Italy

ACTIVE NOT RECRUITING

ASST Fatebenefratelli Sacco

Milan, Italy

RECRUITING

IRCCS Cà Granda Ospedale Maggiore

Milan, Italy

RECRUITING

University Vita-Salute San Raffaele

Milan, Italy

ACTIVE NOT RECRUITING

University Federico II

Naples, Italy

RECRUITING

IRCCS San Matteo

Pavia, Italy

RECRUITING

Related Publications (7)

• Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.

  PMID: 2394349 BACKGROUND

• Gionchetti P, Dignass A, Danese S, Magro Dias FJ, Rogler G, Lakatos PL, Adamina M, Ardizzone S, Buskens CJ, Sebastian S, Laureti S, Sampietro GM, Vucelic B, van der Woude CJ, Barreiro-de Acosta M, Maaser C, Portela F, Vavricka SR, Gomollon F; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 2: Surgical Management and Special Situations. J Crohns Colitis. 2017 Feb;11(2):135-149. doi: 10.1093/ecco-jcc/jjw169. Epub 2016 Sep 22.

  PMID: 27660342 BACKGROUND

• Iacucci M, Ghosh S, Daperno M. Post-operative Recurrence of Crohn's Disease: There Is More to It than Meets the Eye. J Crohns Colitis. 2016 Sep;10(9):999-1000. doi: 10.1093/ecco-jcc/jjw094. Epub 2016 May 4. No abstract available.

  PMID: 27147451 BACKGROUND

• Riviere P, Vermeire S, Irles-Depe M, Van Assche G, Rutgeerts P, de Buck van Overstraeten A, Denost Q, Wolthuis A, D'Hoore A, Laharie D, Ferrante M. No Change in Determining Crohn's Disease Recurrence or Need for Endoscopic or Surgical Intervention With Modification of the Rutgeerts' Scoring System. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1643-1645. doi: 10.1016/j.cgh.2018.09.047. Epub 2018 Oct 4.

  PMID: 30291910 BACKGROUND

• Auzoux J, Boschetti G, Anon B, Aubourg A, Caulet M, Poisson L, Besson P, Lecomte T, Roger S, Picon L, Nancey S, Moussata D, Flourie B. Usefulness of confocal laser endomicroscopy for predicting postoperative recurrence in patients with Crohn's disease: a pilot study. Gastrointest Endosc. 2019 Jul;90(1):151-157. doi: 10.1016/j.gie.2019.02.030. Epub 2019 Mar 5.

  PMID: 30849396 BACKGROUND

• Rispo A, Imperatore N, Testa A, Nardone OM, Luglio G, Caporaso N, Castiglione F. Diagnostic Accuracy of Ultrasonography in the Detection of Postsurgical Recurrence in Crohn's Disease: A Systematic Review with Meta-analysis. Inflamm Bowel Dis. 2018 Apr 23;24(5):977-988. doi: 10.1093/ibd/izy012.

  PMID: 29688470 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

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal biopsies, Blood, Stool, Saliva

MeSH Terms

Conditions

Crohn Disease

Interventions

Colonoscopy; Defecation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marietta Iacucci, Professor

  APC Microbiome Ireland, University College Cork

  STUDY CHAIR

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: July 10, 2024
• First Posted: July 17, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (4); IL (1); IT (7); BE (1); CA (1); DE (1)