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NCT03266471 · ClinicalTrials.gov registry record
Cytokines and Genes in Therapeutic Response in Crohn's Disease
A clinical trial of Inflammatory Bowel Diseases, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 96
- Enrollment target
- 2
- Study locations
NCT03266471: Completed study of Inflammatory Bowel Diseases, sponsored by Vanderbilt University Medical Center.
NCT03266471 is a study of Inflammatory Bowel Diseases that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 96 participants, below the 42,259-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266471, a study of Inflammatory Bowel Diseases, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. At present, there are no reliable mechanisms to predict response to individual IBD medications. The investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. In addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.
Primary Outcome
The investigators will classify Crohn's disease subjects as primary responders or primary non-responders to anti-TNF-α, ustekinumab, or vedolizumab therapy based on clinical, endoscopic, and/or histologic data. The investigators will compare serum and tissue cytokines in CD subjects at before and after treatment initiation.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Baseline blood sample
- DIAGNOSTIC_TEST Baseline intestinal biopsies
- OTHER Crohn's disease activity index (CDAI)
- DIAGNOSTIC_TEST Post treatment blood sample
- DIAGNOSTIC_TEST Post treatment intestinal biopsies
Study Locations (2)
Tennessee
- Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center - Nashville
- Vanderbilt University Medical Center Endoscopy Laboratory - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2022-05-03 |
What the finished NCT03266471 record still lists
NCT03266471 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 42,259-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 5 interventions - of which Baseline blood sample is the first listed.
NCT03266471 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03266471 about?
NCT03266471 is a clinical study titled "Cytokines and Genes in Therapeutic Response in Crohn's Disease". Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, vari...
What is the current status of trial NCT03266471?
This trial is currently completed. The enrollment target is 96 participants. The study started on 2017-10-13. Estimated completion is 2022-05-03.
What conditions does trial NCT03266471 study?
This clinical trial studies the following conditions: Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT03266471?
The interventions under investigation include: Baseline blood sample (DIAGNOSTIC_TEST), Baseline intestinal biopsies (DIAGNOSTIC_TEST), Crohn's disease activity index (CDAI) (OTHER), Post treatment blood sample (DIAGNOSTIC_TEST), Post treatment intestinal biopsies (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03266471?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03266471 being conducted?
This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03266471's enrollment target sits among peer trials
96 25th of 48 higher than 24 of 48 other Inflammatory Bowel Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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