Ulcerative ColitisNCT06516341
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
An observational study of Ulcerative Colitis and Crohn Disease, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease
- What is being tested?
- CD patients and UC patients
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2025to Sep 2026
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational multicenter study with additional procedures performed on patients with an established diagnosis of UC and CD. It consists of a prospective and a retrospective part. The prospective part involves surgical leftover and blood collected at the time of surgery ad hoc for the study, without other risks for the patients. For the retrospective analysis, paraffin-embedded specimens already stored in the pathology unit from at least two years before the project starting date (from 1st August 2022 to 31st August 2024), will be used. Moreover, we will select and include in this study adult (age ≥18 years) patients with histologically confirmed CD or UC who have undergone surgery as per standard of care and whose surgical tissue- and blood-derived cell-suspensions have been previously collected for the already approved project IBD Biobank and stored at -80° C. The retrospective analysis will include IBD biobank samples collected since 1st August 2022 up to August 2024.
Who may be able to join
- adult (age >18 years) patients with histologically confirmed CD or UC undergoing intestinal resection due to stricturing disease, regardless of their current or past medical treatment;
- given that it is an observational study, also pregnant and breastfeeding patients could be included;
- able and willing to sign the informed consent.
Who cannot join
- patients <18 years or > 70 years;
- patients with unconfirmed both UC and CD diagnoses;
- patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible;
- patients unable or unwilling to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Pierpaolo Sileri, MD, PhD., +39 0226436275, sileri.pierpaolo@hsr.it
Federica Ungaro, PhD., +39 0226437864, ungaro.federica@hsr.it
About this study
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:
- defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors
- integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care.
This project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.
Read the detailed description
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:
- defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors
- integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients.
This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per standard of care. This project will reveal possible causes and build methods that could help predict postoperative complications ultimately resulting in changes in clinical management.
- Conditions
- Ulcerative Colitis, Crohn Disease
- Being tested
- CD patients, UC patients
- Keywords
- Ulcerative Colitis, Crohn Disease, Stenosis, Post-operative recurrence, IBD, Biomarker prediction, Stricturing disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD patientsProcedure or surgery
The study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery
UC patientsProcedure or surgery
The study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery
| Study group | Role | What they receive |
|---|---|---|
| UC patients | Patients with histologically confirmed UC undergoing intestinal resection due to stricturing disease. These patients will be divided into two groups:
patients with (case group) and without (control group) postoperative recurrence Receives: Procedure: UC patients | |
| CD patients | Patients with histologically confirmed CD undergoing intestinal resection due to stricturing disease. Divided into two groups: patients with (case group) and without (control group) postoperative recurrence Receives: Procedure: CD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define spatial, cellular, and molecular characteristics of IBD-derived intestinal samples
To define the spatial transcriptome of UC and CD-derived intestinal mucosa, IBD-derived tissues will be analized by spatial transcriptomics, either at molecular or at microbiota level on formalin-fixed paraffin-embedded (FFPE) tissues stored at our pathology unit.
Measured: 6 months from surgery
Secondary outcomes (2)
To build the predictive model of postoperative complications based on spatially and temporally resolved IBD characteristics
Other variables to be considered are CD4+ T-cells from the processing of blood
Measured: 6-12 months from surgery
To determine the mechanism underlying post-operative complications by exploiting in-vivo (mouse) experimental models of intestinal inflammation.
At the time of surgery, feces will be collected from patients. The microbial component from the IBD surgical specimens will be isolated and injected into humanized animal models.
Measured: 19-24 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start27 Feb 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Casa Sollievo della Sofferenza, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Ministero della Salute, Italy
- Responsible party
- Principal investigator, Pierpaolo Sileri, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516341
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12377779
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
- ClinicalTrials.gov ID
- NCT06516341
- Acronym / sponsor ID
- PNRR-MCNT2-2023-12377779
- Conditions
- Ulcerative Colitis, Crohn Disease
- Keywords
- Ulcerative Colitis, Crohn Disease, Stenosis, Post-operative recurrence, IBD, Biomarker prediction, Stricturing disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- IRCCS Casa Sollievo della Sofferenza, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Ministero della Salute, Italy
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 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.
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:
- defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors
- integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care.
This project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.
Detailed description
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:
- defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors
- integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients.
This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per standard of care. This project will reveal possible causes and build methods that could help predict postoperative complications ultimately resulting in changes in clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC patients | – | Procedure: UC patientsPatients with histologically confirmed UC undergoing intestinal resection due to stricturing disease. These patients will be divided into two groups: patients with (case group) and without (control group) postoperative recurrence |
| CD patients | – | Procedure: CD patientsPatients with histologically confirmed CD undergoing intestinal resection due to stricturing disease. Divided into two groups: patients with (case group) and without (control group) postoperative recurrence |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational multicenter study with additional procedures performed on patients with an established diagnosis of UC and CD. It consists of a prospective and a retrospective part. The prospective part involves surgical leftover and blood collected at the time of surgery ad hoc for the study, without other risks for the patients. For the retrospective analysis, paraffin-embedded specimens already stored in the pathology unit from at least two years before the project starting date (from 1st August 2022 to 31st August 2024), will be used. Moreover, we will select and include in this study adult (age ≥18 years) patients with histologically confirmed CD or UC who have undergone surgery as per standard of care and whose surgical tissue- and blood-derived cell-suspensions have been previously collected for the already approved project IBD Biobank and stored at -80° C. The retrospective analysis will include IBD biobank samples collected since 1st August 2022 up to August 2024.
Key inclusion criteria (3 listed)
- adult (age >18 years) patients with histologically confirmed CD or UC undergoing intestinal resection due to stricturing disease, regardless of their current or past medical treatment;
- given that it is an observational study, also pregnant and breastfeeding patients could be included;
- able and willing to sign the informed consent.
Key exclusion criteria (4 listed)
- patients <18 years or > 70 years;
- patients with unconfirmed both UC and CD diagnoses;
- patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible;
- patients unable or unwilling to sign the 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 |
|---|---|---|
| CD patientsThe study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery | Procedure or surgery | CD patients |
| UC patientsThe study will involve the collection of leftover surgical material after pathologist analysis, mucosal brushes, an additional volume of blood and feces of patients at the time of surgery | Procedure or surgery | UC patients |
Primary outcome
To define spatial, cellular, and molecular characteristics of IBD-derived intestinal samples
Time frame: 6 months from surgery
To define the spatial transcriptome of UC and CD-derived intestinal mucosa, IBD-derived tissues will be analized by spatial transcriptomics, either at molecular or at microbiota level on formalin-fixed paraffin-embedded (FFPE) tissues stored at our pathology unit.
2 secondary outcomes
To build the predictive model of postoperative complications based on spatially and temporally resolved IBD characteristics
Time frame: 6-12 months from surgery
To determine the mechanism underlying post-operative complications by exploiting in-vivo (mouse) experimental models of intestinal inflammation.
Time frame: 19-24 months from surgery
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 14 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn Disease, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
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 4 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Pierpaolo Sileri, MD. PhD. (+39 0226436275, sileri.pierpaolo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define spatial, cellular, and molecular characteristics of IBD-derived intestinal samples (time frame: 6 months from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.