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NCT04113733 · ClinicalTrials.gov registry record
Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas
A clinical trial of Crohn Disease, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- 178
- Enrollment target
- 1
- Study location
NCT04113733 is a study of Crohn Disease that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 178 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04113733, a study of Crohn Disease, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 178 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Sample Collection
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2027-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04113733
The ClinicalTrials.gov registry entry for NCT04113733 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (12% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention - of which Sample Collection is the first listed.
NCT04113733 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04113733 about?
NCT04113733 is a clinical study titled "Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas". 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 s...
What is the current status of trial NCT04113733?
This trial is currently active not recruiting. The enrollment target is 178 participants. The study started on 2019-12-17. Estimated completion is 2027-02.
What conditions does trial NCT04113733 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT04113733?
The interventions under investigation include: Sample Collection (OTHER).
Who is sponsoring clinical trial NCT04113733?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04113733 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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