Crohn DiseasePROSPERNCT06505304
AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
An observational study of Crohn Disease, run by University College Cork at 15 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Colonoscopy, Intestinal biopsies and Confocal laser endomicroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 225 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 1 May 2024to 31 May 2026
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Italy7 sites, 4 recruiting
- Active, not recruiting
ASST Spedali Civili
Brescia
- Recruiting
ASST Fatebenefratelli Sacco
Milan
Rosanna Cannatelli, cannatelli.rosanna@asst-fbf-sacco.it
Rosanna Cannatelli, Dr
- Recruiting
IRCCS Cà Granda Ospedale Maggiore
Milan
Gianeugenio Tontini, Professor, gianeugenio.tontini@policlinico.mi.it
Gianeugenio Tontini, Professor
- Active, not recruiting
University Vita-Salute San Raffaele
Milan
- Recruiting
University Federico II
Naples
Olga Maria Nardone, Dr, olgamaria.nardone@unina.it
Fabiana Castiglione, Professor
- Recruiting
IRCCS San Matteo
Pavia
Mariangela Delliponti, M.Delliponti@smatteo.pv.it
Antonio Di Sabatino, Professor
- Active, not recruiting
Istituto Clinico Humanitas
Rozzano, Milan
Ireland4 sites, 1 recruiting
- Active, not recruiting
Cork University Hospital
Cork
- Active, not recruiting
Mercy University Hospital
Cork
- Recruiting
University College Dublin
Dublin
Janet Rebollos, jmrebollos@yahoo.com
Glen Doherty, Professor
- Active, not recruiting
University College Hospitals Galway
Galway
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary
Cathy Liu, luc@ucalgary.ca
Remo Panaccione, Professor
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Centre
Tel Aviv
Shaked Cohen, shakedcoh@clalit.org.il
Henit Yanai, Professor
About this study
Official title: Endoscopic Multimodal Assessment Using Advanced Imaging Integrated AI to Predict Recurrence in pOSt-oPerativE CRohn's Disease - PROSPER Study
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.
Read the detailed description
Background:
Up to 70% of Crohn's disease (CD) patients will undergo a surgical resection in their lifetime. However, surgery is non-curative since 50% of patients have a recurrence, and about one-third need repeat surgery. The tools currently used to assess CD recurrences, such as faecal calprotectin (FCP), cross-sectional imaging (small bowel ultrasound, MRI scan) and conventional endoscopy, have a limited role in predicting early Post-Operative CD recurrence (POCr). Distinguishing inflammatory disease recurrence from post-surgical ischemic or suture-related alterations poses a significant challenge. Endoscopic Enhanced imaging (EEI) techniques like virtual electronic chromoendoscopy (VCE) and biopsy-like probe-based confocal laser endomicroscopy (pCLE) combined with artificial intelligence, can improve the detection of mucosal/vascular changes before major alterations become evident. VCE is available simply by switching a button. The pCLE probe will be passed through the endoscope channel like a biopsy forceps, enabling real-time, histology-like images of the intestine's lining and the gut barrier.
Study 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 CD.
The investigators will develop a novel endoscopic assessment system using EEI to evaluate early post-surgical changes and predict 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. A detailed exploratory analysis will only be done in a cohort of patients in Ireland. The correlation between the new scoring system and established endoscopic and histologic scores, cross-sectional imaging, and non-invasive markers of inflammation will be evaluated. A multimodal machine learning model will be developed on EEI videos, histology, clinical data and immune molecular analysis to stratify patients' risk of early recurrence and long-term outcomes. The study will be divided into three phases:
- In the first phase, descriptor criteria for the assessment of post-operative Crohn's Disease will be defined. Gastroenterologists experienced in IBD endoscopy will review images and videos from an existing library showing the different grade of inflammation of the modified Rutgeerts score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted to ensure equal participation and identify the best component descriptors of endoscopic recurrence of CD. The components that achieved 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. Further, the investigators will first validate the new endoscopic score using the first 30 consecutive VCE and pCLE videos of POCr patients recruited in the multicenter PROSPER study. A structured consensus will be conducted with experts in Inflammatory Bowel Disease, endoscopy and histology to define the endoscopic findings of mucosal, vascular and intestinal barrier function. Subsequently, the investigators will prospectively validate the score in a large cohort of POCr patients enrolled in the PROSPER study and assess the diagnostic accuracy of the new scoring system in predicting post-surgical recurrence. Clinical information, blood, saliva, stool, and bowel specimens will be taken. Cross-sectional imaging (magnetic resonance imaging -MRI-, intestinal ultrasound -IUS-), endoscopy VCE and pCLE (in equipped centres) will be performed according to stool calprotectin 3 months after surgery. Patients will be followed up for 24 months and the results of the follow-up colonoscopy performed, as standard of care, within 18 months from the index colonoscopy, will be collected.
- In the second phase, the investigators will externally validate and reproduce the new scoring system by gastroenterologists using a computerized training module.
- In the third phase, an advanced computer-aided quantitative analysis of videos, images from VCE and pCLE, and digital histology will be developed and validated to enhance the prediction of POCr. Additionally, further machine learning models will be developed, utilizing comprehensive data from blood, stool, cross-sectional imaging, endoscopy, histology, immune markers, and OMICs to predict POCr and long-term outcomes.
- Conditions
- Crohn Disease
- Being tested
- Colonoscopy, Intestinal biopsies, Confocal laser endomicroscopy, Intestinal ultrasound, Stool
- Keywords
- Crohn's disease, Artificial Intelligence, Virtual Chromoendoscopy, Confocal laser endomicroscopy, OMIC, Machine Learning, Post-operative recurrence
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
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 biopsiesProcedure or surgery
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 endomicroscopyProcedure or surgery
pCLE with fluorescein injection will be performed during index colonoscopy, in centres where is available, to assess early alteration of the barrier function.
Intestinal ultrasoundProcedure or surgery
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.
StoolDiagnostic 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).
BloodDiagnostic 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).
SalivaDiagnostic 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)
Clinical follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-operative CD | Patients undergoing surgery or with a previous (within 3 months from the enrolment) surgery for CD Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months and 6 months
Secondary outcomes (3)
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 and
- new surgery at 12 and 24 months after colonoscopy.
Measured: 1 year and 2 years
Early post-operative histological recurrence
Post surgical histologic recurrence will be defined as Robarts histopathology index (RHI) >3 and PICaSSO Histological remission Index (PHRI) > 0
Measured: 3 months or 6 months
Early post-operative IUS recurrence
Post surgical IUS recurrence will be assessed according to:
- Anastomotic bowel wall thickness (BWT)
- Bowel wall stratification (BWS)
- Lesion length
- Presence of mesenteric lymphadenopathy
- Proliferation of inflammatory mesenteric fat (iFat).
- Presence of free fluid within the peritoneal cavity
- Presence of strictures
- Presence of fistulae
- Presence of abscesses
- Limberg score
Measured: 3 months or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 May 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Marietta Iacucci, Professor, Study chair, APC Microbiome Ireland, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505304
- Sponsor's protocol ID
- APC188
- Acronym
- PROSPER
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2394349Gionchetti 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.
PubMed 27660342Iacucci 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.
PubMed 27147451Riviere 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.
PubMed 30291910Auzoux 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.
PubMed 30849396Rispo 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.
PubMed 29688470Iacucci 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 36228649
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Multimodal Assessment Using Advanced Imaging Integrated AI to Predict Recurrence in pOSt-oPerativE CRohn's Disease - PROSPER Study
- ClinicalTrials.gov ID
- NCT06505304
- Acronym / sponsor ID
- PROSPER / APC188
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, Artificial Intelligence, Virtual Chromoendoscopy, Confocal laser endomicroscopy, OMIC, Machine Learning, Post-operative recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Jul 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 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.
Detailed description
Background:
Up to 70% of Crohn's disease (CD) patients will undergo a surgical resection in their lifetime. However, surgery is non-curative since 50% of patients have a recurrence, and about one-third need repeat surgery. The tools currently used to assess CD recurrences, such as faecal calprotectin (FCP), cross-sectional imaging (small bowel ultrasound, MRI scan) and conventional endoscopy, have a limited role in predicting early Post-Operative CD recurrence (POCr). Distinguishing inflammatory disease recurrence from post-surgical ischemic or suture-related alterations poses a significant challenge. Endoscopic Enhanced imaging (EEI) techniques like virtual electronic chromoendoscopy (VCE) and biopsy-like probe-based confocal laser endomicroscopy (pCLE) combined with artificial intelligence, can improve the detection of mucosal/vascular changes before major alterations become evident. VCE is available simply by switching a button. The pCLE probe will be passed through the endoscope channel like a biopsy forceps, enabling real-time, histology-like images of the intestine's lining and the gut barrier.
Study 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 CD.
The investigators will develop a novel endoscopic assessment system using EEI to evaluate early post-surgical changes and predict 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. A detailed exploratory analysis will only be done in a cohort of patients in Ireland. The correlation between the new scoring system and established endoscopic and histologic scores, cross-sectional imaging, and non-invasive markers of inflammation will be evaluated. A multimodal machine learning model will be developed on EEI videos, histology, clinical data and immune molecular analysis to stratify patients' risk of early recurrence and long-term outcomes. The study will be divided into three phases:
- In the first phase, descriptor criteria for the assessment of post-operative Crohn's Disease will be defined. Gastroenterologists experienced in IBD endoscopy will review images and videos from an existing library showing the different grade of inflammation of the modified Rutgeerts score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted to ensure equal participation and identify the best component descriptors of endoscopic recurrence of CD. The components that achieved 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. Further, the investigators will first validate the new endoscopic score using the first 30 consecutive VCE and pCLE videos of POCr patients recruited in the multicenter PROSPER study. A structured consensus will be conducted with experts in Inflammatory Bowel Disease, endoscopy and histology to define the endoscopic findings of mucosal, vascular and intestinal barrier function. Subsequently, the investigators will prospectively validate the score in a large cohort of POCr patients enrolled in the PROSPER study and assess the diagnostic accuracy of the new scoring system in predicting post-surgical recurrence. Clinical information, blood, saliva, stool, and bowel specimens will be taken. Cross-sectional imaging (magnetic resonance imaging -MRI-, intestinal ultrasound -IUS-), endoscopy VCE and pCLE (in equipped centres) will be performed according to stool calprotectin 3 months after surgery. Patients will be followed up for 24 months and the results of the follow-up colonoscopy performed, as standard of care, within 18 months from the index colonoscopy, will be collected.
- In the second phase, the investigators will externally validate and reproduce the new scoring system by gastroenterologists using a computerized training module.
- In the third phase, an advanced computer-aided quantitative analysis of videos, images from VCE and pCLE, and digital histology will be developed and validated to enhance the prediction of POCr. Additionally, further machine learning models will be developed, utilizing comprehensive data from blood, stool, cross-sectional imaging, endoscopy, histology, immune markers, and OMICs to predict POCr and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-operative 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-upPatients undergoing surgery or with a previous (within 3 months from the enrolment) surgery for CD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Inability to provide consent.
- Presence of serious co-morbidities (clinical contraindication).
- Presence of ostomy.
- Pregnancy or breastfeeding.
- Contraindication for colonoscopy or biopsies.
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 |
|---|---|---|
| ColonoscopyThe 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. | Procedure or surgery | Post-operative CD |
| Intestinal biopsiesDuring 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. | Procedure or surgery | Post-operative CD |
| Confocal laser endomicroscopypCLE with fluorescein injection will be performed during index colonoscopy, in centres where is available, to assess early alteration of the barrier function. | Procedure or surgery | Post-operative CD |
| Intestinal ultrasoundAll 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. | Procedure or surgery | Post-operative CD |
| StoolStool 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). | Diagnostic test | Post-operative CD |
| BloodBlood 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). | Diagnostic test | Post-operative CD |
| SalivaSaliva 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) | Diagnostic test | Post-operative CD |
| Clinical follow-upPatients 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. | Other | Post-operative CD |
Primary outcome
Early post-operative endoscopic recurrence
Time frame: 3 months or 6 months
Post surgical endoscopic recurrence will be defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) > 2 and Rutgeerts score > i2a
Early post-operative clinical recurrence
Time frame: 3 months and 6 months
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 secondary outcomes
Post-operative clinical recurrence
Time frame: 1 year and 2 years
Early post-operative histological recurrence
Time frame: 3 months or 6 months
Early post-operative IUS recurrence
Time frame: 3 months or 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 2394349Rutgeerts 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.
- Background: PubMed 27660342Gionchetti 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.
- Background: PubMed 27147451Iacucci 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.
- Background: PubMed 30291910Riviere 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.
- Background: PubMed 30849396Auzoux 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.
- Background: PubMed 29688470Rispo 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.
- 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.
- 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.
Marietta Iacucci, Professor study chair
APC Microbiome Ireland, University College Cork
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by University College Cork at 15 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 11 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Ireland, Belgium, Canada, Germany 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?
Results are not available in the source record.
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?
Early post-operative endoscopic recurrence (time frame: 3 months or 6 months). 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 NCT06505304, which also lists 7 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 18 Jul 2024.