Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating DiseaseNCT06484738
Spatially Resolved IBD: Spatial Transcriptomics of Inflammatory Bowel Disease (IBD)
An observational study of Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease and Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease, run by IRCCS San Raffaele at 2 sites in Italy.
Trial summary
The goal of this retrospective observational study is to obtain the spatial resolution of the entire intestinal fibrotic process through the technology STOmics Stereoseq. For this study we will use surgical specimens from 8 UC e 8 CD previously collected for the already approved project, IBD Biobank, and stored at… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease, Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease
- What is being tested?
- transcriptomic analysis
- How many people
- 16 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2024to Aug 2025
- 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 69 years
- All sexes
- Adult, Older adult
Study population: Retrospective observational study involving patients with Crohn's disease (CD) (n=8) and patients with ulcerative colitis (UC)(n=8) who had undergone surgery according to the standard of care. We will use the biological material from surgery carried out for normal clinical practice, and already stored at -80°C for IBD Biobank project. The retrospective referral period of time goes from July 2022 until July 2023.
Who may be able to join
- adult patient (age ≥18 years), both male and female patients with histologically confirmed CD and UC undergoing intestinal resection according to standard of care due to complicating disease, regardless of their current or past medical treatment;
- patients that have signed the IBD Biobank informed consent and consented to the use of their own biological material in future study or pertaining to the same field of investigation.
Who cannot join
- - 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 who have not signed the IBD Biobank informed consent.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Ospedale San Raffaele
Milan
Irccs Ospedale San Raffaele
Milan, 20132
About this study
The goal of this retrospective observational study is to obtain the spatial resolution of the entire intestinal fibrotic process through the technology STOmics Stereoseq. For this study we will use surgical specimens from 8 UC e 8 CD previously collected for the already approved project, IBD Biobank, and stored at -80° C.
Read the detailed description
This is a monocentric observational study in which we will use the biological material from surgery carried out for normal clinical practice, and already stored at -80°C.
This project has as purpose:
- To unravel the changes in the intestine leading to complications in CD and UC patients. In particular, we aim to identify the cell populations, their spatial organization, interactions, and specific transcriptional shifts, leading the progression from healthy tissue to inflamed and from inflamed to fibrotic tissue. We will be interested in producing a profile of Spatial transcriptomics of all areas of the surgical specimen.
- To compare the spatial organization and differential gene expression of tissue
- Conditions
- Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease, Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease
- Being tested
- transcriptomic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcriptomic analysisOther
to use their biological samples from UC and CD patients, already stored at -80°C for transcriptomic analysis through STOmics Stereoseq
| Study group | Role | What they receive |
|---|---|---|
| patients with histologically confirmed CD | patients with histologically confirmed CD undergoing intestinal resection Receives: Other: transcriptomic analysis | |
| patients with histologically confirmed UC | patients with histologically confirmed UC undergoing intestinal resection Receives: Other: transcriptomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients
to perform a transcriptomic analysis of the entire surgical specimen will be embedded in OCT block. To overcome any failures in the OCT embedding, we will cut serial sections and stain them to evaluate the presence of all intestinal regions of interest, and then choose the adjacent one for the spatial analysis. Moreover, we will evaluate by histological assessment whether one single piece of surgical specimen will encompass not inflamed, inflamed (in case of UC) and also fibrotic areas (in case of CD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating 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
- Retrospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- BGI, China
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484738
- Sponsor's protocol ID
- STOmics
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially Resolved IBD: Spatial Transcriptomics of Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT06484738
- Acronym / sponsor ID
- STOmics
- Conditions
- Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease, Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- BGI, China
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 3 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.
The goal of this retrospective observational study is to obtain the spatial resolution of the entire intestinal fibrotic process through the technology STOmics Stereoseq. For this study we will use surgical specimens from 8 UC e 8 CD previously collected for the already approved project, IBD Biobank, and stored at -80° C.
Detailed description
This is a monocentric observational study in which we will use the biological material from surgery carried out for normal clinical practice, and already stored at -80°C.
This project has as purpose:
- To unravel the changes in the intestine leading to complications in CD and UC patients. In particular, we aim to identify the cell populations, their spatial organization, interactions, and specific transcriptional shifts, leading the progression from healthy tissue to inflamed and from inflamed to fibrotic tissue. We will be interested in producing a profile of Spatial transcriptomics of all areas of the surgical specimen.
- To compare the spatial organization and differential gene expression of tissue
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with histologically confirmed CD | – | Other: transcriptomic analysispatients with histologically confirmed CD undergoing intestinal resection |
| patients with histologically confirmed UC | – | Other: transcriptomic analysispatients with histologically confirmed UC undergoing intestinal resection |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Retrospective observational study involving patients with Crohn's disease (CD) (n=8) and patients with ulcerative colitis (UC)(n=8) who had undergone surgery according to the standard of care. We will use the biological material from surgery carried out for normal clinical practice, and already stored at -80°C for IBD Biobank project. The retrospective referral period of time goes from July 2022 until July 2023.
Key inclusion criteria (2 listed)
- adult patient (age ≥18 years), both male and female patients with histologically confirmed CD and UC undergoing intestinal resection according to standard of care due to complicating disease, regardless of their current or past medical treatment;
- patients that have signed the IBD Biobank informed consent and consented to the use of their own biological material in future study or pertaining to the same field of investigation.
Key exclusion criteria (3 listed)
- - 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 who have not signed the IBD Biobank 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 |
|---|---|---|
| transcriptomic analysisto use their biological samples from UC and CD patients, already stored at -80°C for transcriptomic analysis through STOmics Stereoseq | Other | patients with histologically confirmed CD, patients with histologically confirmed UC |
Primary outcome
Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients
Time frame: 1 year
to perform a transcriptomic analysis of the entire surgical specimen will be embedded in OCT block. To overcome any failures in the OCT embedding, we will cut serial sections and stain them to evaluate the presence of all intestinal regions of interest, and then choose the adjacent one for the spatial analysis. Moreover, we will evaluate by histological assessment whether one single piece of surgical specimen will encompass not inflamed, inflamed (in case of UC) and also fibrotic areas (in case of CD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease and Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease, run by IRCCS San Raffaele at 2 sites 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 2 inclusion and 3 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 3 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients (time frame: 1 year). 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 3 Jul 2024.