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

NCT ID: NCT06484738

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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

Conditions

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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 Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with histologically confirmed CD

patients with histologically confirmed CD undergoing intestinal resection

transcriptomic analysis

Intervention Type 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 UC

patients with histologically confirmed UC undergoing intestinal resection

transcriptomic analysis

Intervention Type OTHER

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

Interventions

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transcriptomic analysis

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BGI, China

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Silvio Danese

Professore

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Irccs Ospedale San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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STOmics

Identifier Type: -

Identifier Source: org_study_id

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