NCT04113733

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 178 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	Sample Collection	Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Timeline

• Start date: 2019-12-17
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2019-10-03
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States