Recruiting

Endoscopic Prediction

Sponsor:

University College Cork

Code:

NCT06505304

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Colonoscopy

Intestinal biopsies

Confocal laser endomicroscopy

Intestinal ultrasound

Stool

Study Details

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

Study ID

NCT06505304

Start date

May 1, 2024

Status verified date

Jul, 2024

Completion date

May 31, 2026

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Exclusion criteria for pCLE only:

  • 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.

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Post-operative CD

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

Interventions

Colonoscopy

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.

Intestinal biopsies

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.

Confocal laser endomicroscopy

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

Intestinal ultrasound

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.

Stool

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).

Blood

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).

Saliva

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)

Clinical follow-up

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.

Primary outcome measure

  • Early post-operative endoscopic recurrence [ Time Frame: 3 months or 6 months ]
  • Early post-operative clinical recurrence [ Time Frame: 3 months and 6 months ]

Central Contacts and Locations

Central contacts

Michelle O'Riordan

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

Locations

University of Calgary

Recruiting

Calgary, Canada

Contacts

Cathy Liu

luc@ucalgary.ca

Principal Investigator:

Remo Panaccione, Professor

More Information

Sponsor

University College Cork

Last update posted

Jul 18, 2024

Last verified

Jul, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University College Cork on 2024-07-18.