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ACTIVE NOT RECRUITING
NCT04113733

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

178

Start Date

2019-12-17

Completion Date

2027-02

Last Updated

2025-11-04

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Sample Collection

Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States