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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06484738
Enrollment
16
Registered
2024-07-03
Start date
2024-08-31
Completion date
2025-08-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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: 1. 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. 2. To compare the spatial organization and differential gene expression of tissue

Interventions

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

Sponsors

BGI, China
CollaboratorOTHER
IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years

Inclusion criteria

* 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.

Exclusion criteria

* \- 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.

Design outcomes

Primary

MeasureTime frameDescription
Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients1 yearto 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026