跳至主要内容
临床试验/NCT04113733
NCT04113733进行中(未招募)不适用

Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2019年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
178
试验地点
1
主要终点
The change in cellular composition (i.e., percentage of cell types) between Crohn's disease and control patients as assessed by single-cell RNA sequencing analysis, RNA-fluorescence in situ hybridization, and multiplex immunofluorescence.

研究概览

简要总结

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis, affects more than 1.6 million people in the United States alone. Despite current therapies, remission only occurs in approximately half of patients. The goal of study is to map single-cell spatial relationships across the spectrum of ileum/ascending colon from healthy control patients to uninvolved/quiescent and involved/active CD patients and assess for relationships between single-cell data and patient clinical data.

The investigators will utilize endoscopic mucosal biopsies and surgical resection specimens with rapid transfer of fresh tissue to the single-cell preparation for RNA-sequencing and use of tissues for RNA-fluorescence in situ hybridization and multiplex immunofluorescence. Along with machine learning image analysis and bioinformatics, this will generate a robust/detailed single-cell gut cell atlas (GCA) of ileo-colonic CD at all disease activities versus normal tissues. The study will also compare the results of endoscopic mucosal biopsies to those obtained from full thickness surgical specimens by utilizing the Cooperative Human Tissue Network (CHTN).

The investigators anticipate the GCA data will provide new insights into disease pathogenesis, leading to new therapeutic targets.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The change in cellular composition (i.e., percentage of cell types) between Crohn's disease and control patients as assessed by single-cell RNA sequencing analysis, RNA-fluorescence in situ hybridization, and multiplex immunofluorescence.

时间窗: 36 months

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

Lori Coburn

Principle Investigator

Vanderbilt University Medical Center

研究点 (1)

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