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

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Other: Sample Collection

• Registration Number: NCT04113733
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2019-12-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's Disease	Sample Collection	This group consists of patients with a diagnosis of Crohn's disease undergoing colonoscopy for clinical care. Samples including tissue biopsy, blood and stool will be collected one time. In addition, patient information that may include questionnaires and medical record review will be collected.
Control	Sample Collection	This group will include patients undergoing screening colonoscopy as part of standard of care. Samples including tissue biopsy, blood and stool will be collected one time. In addition, patient information that may include questionnaires and medical record review will be collected.

Primary Outcome Measures

Name	Time	Method
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.	36 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States