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NCT03566407 · ClinicalTrials.gov registry record · NA
Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
A NA study, sponsored by Prometheus Laboratories.
- Terminated
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT03566407: Clinical Trial NA study, sponsored by Prometheus Laboratories.
NCT03566407 is a NA study that was terminated before completion, run by Prometheus Laboratories. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03566407, a NA study, was terminated before completion, sponsored by Prometheus Laboratories.
- TERMINATED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.
Primary Outcome
The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater
Interventions
- PROCEDURE Colonoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-05-04 |
| Est. Completion | 2019-03-29 |
| Phase | NA |
Why NCT03566407 stopped before completion
NCT03566407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Colonoscopy is the first listed.
NCT03566407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03566407 about?
NCT03566407 is a clinical study titled "Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients". To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time cor...
What is the current status of trial NCT03566407?
This trial is currently terminated. It is a NA study. The enrollment target is 41 participants. The study started on 2018-05-04. Estimated completion is 2019-03-29.
What interventions are being tested in trial NCT03566407?
The interventions under investigation include: Colonoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT03566407?
This trial is sponsored by Prometheus Laboratories, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03566407's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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