Spatially Resolved IBD: Spatial Transcriptomics of Inflammatory Bowel Disease (IBD)

NCT06484738 | Not Yet Recruiting

• 1 other identifier: STOmics
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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 -80° C.

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

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Study Arms (2)

patients with histologically confirmed CD

patients with histologically confirmed CD undergoing intestinal resection

Other: transcriptomic analysis

patients with histologically confirmed UC

patients with histologically confirmed UC undergoing intestinal resection

Other: transcriptomic analysis

Interventions

transcriptomic analysis OTHER

to use their biological samples from UC and CD patients, already stored at -80°C for transcriptomic analysis through STOmics Stereoseq

patients with histologically confirmed CD; patients with histologically confirmed UC

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• BGI, China: collaborator

Study Sites (2)

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Irccs Ospedale San Raffaele

Milan, 20132, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)