跳至主要内容
临床试验/NCT06484738
NCT06484738尚未招募不适用

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

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
2
主要终点
Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •- 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.

结局指标

主要结局

Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvio Danese

Professore

IRCCS San Raffaele

研究点 (2)

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