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NCT07035158 · ClinicalTrials.gov registry record
DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis
A clinical trial of Cirrhosis, Liver, sponsored by Owlstone.
- Recruiting
- Registry status
- 240
- Enrollment target
- 4
- Study locations
NCT07035158: Recruiting study of Cirrhosis, Liver, sponsored by Owlstone.
NCT07035158 is a study of Cirrhosis, Liver that is actively recruiting participants, run by Owlstone. The registered enrollment target is 240 participants, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target. The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07035158, a study of Cirrhosis, Liver, is actively recruiting participants, sponsored by Owlstone.
- RECRUITING
- Registry status
- 240 participants
- Enrollment target
- 4
- Study locations
Study Summary
Owlstone Medical has demonstrated that the use of an Exogenous Volatile Organic Compound (EVOC) that targets specific metabolic processes linked to cirrhosis pathophysiology enables identification of subjects with cirrhosis with high accuracy compared to healthy controls. This approach relies on the oral administration of food additives that are metabolized in the liver resulting in volatile end-products exhaled in breath. The presence of liver cirrhosis alters the metabolism of these EVOC-probes altering the breath concentrations of the end-products. These alterations can be used to identify subjects who have a risk of having liver cirrhosis. The study is designed as a case control study comparing subjects with cirrhosis against controls originating from a group of subjects with clinical suspicion of cirrhosis. Adequate balancing of subjects across definitive, probable, possible, and absent cirrhosis groups will be assured through a recruitment enrichment strategy. The primary output of the study will be an algorithm to calculate a risk score for the presence of cirrhosis. As a secondary objective sensitivity analysis will be performed to assess the impact of subject characteristics and cirrhosis etiology on test performance to assure robustness of the test in a deployment setting. The results of this study will inform test optimization for a prospective clinical validation trial, with the goal of developing a test that is widely applicable and available in primary care centers
Primary Outcome
The primary objective is to develop a model for determining the risk of the presence of liver cirrhosis based on breath biomarkers and anthropometric factors in a population comprising individuals at risk of liver cirrhosis warranting expert diagnostic evaluation. This will be a cross validated risk model reporting likelihood of the presence of cirrhosis. Model performance will be evaluated using AUC, specificity, sensitivity, NPV, PPV negative and positive likelihood ratios.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Libra Oral Solution
Study Locations (4)
Other
- Hospital Padre Hurtrado - Santiago
- Norfolk and Norwich Hospital - Norwich
- Peterborough City Hospital - Peterborough
Arizona
- Arizona Liver Health - Chandler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2025-12 |
What NCT07035158 shows while recruiting
NCT07035158 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target.
The record links to 1 condition, with Cirrhosis, Liver appearing as the primary indexed condition, and to 1 intervention - of which Libra Oral Solution is the first listed.
NCT07035158 reports a single indexed study location in Other, Arizona.
Frequently Asked Questions
What is clinical trial NCT07035158 about?
NCT07035158 is a clinical study titled "DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis". Owlstone Medical has demonstrated that the use of an Exogenous Volatile Organic Compound (EVOC) that targets specific metabolic processes linked to cirrhosis pathophysiology enables identification of subjects with cirrhosis with high accuracy compared to healthy controls. This approach relies on the...
What is the current status of trial NCT07035158?
This trial is currently recruiting. The enrollment target is 240 participants. The study started on 2024-05-10. Estimated completion is 2025-12.
What conditions does trial NCT07035158 study?
This clinical trial studies the following conditions: Cirrhosis, Liver.
What interventions are being tested in trial NCT07035158?
The interventions under investigation include: Libra Oral Solution (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07035158?
This trial is sponsored by Owlstone, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07035158 being conducted?
This trial has 4 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07035158's enrollment target sits among peer trials
240 10th of 34 higher than 25 of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver 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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