Clinical Research Directory
Browse clinical research sites, groups, and studies.
DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis
Sponsor: Owlstone Ltd
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
Official title: A Case Control Study in a Population With Clinical Suspicion of Liver Cirrhosis to Develop a Risk Model for the Presence of Cirrhosis Using Breath Biomarkers/EVOC Probes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
240
Start Date
2024-05-10
Completion Date
2025-12
Last Updated
2025-09-03
Healthy Volunteers
No
Conditions
Interventions
Libra Oral Solution
EVOC Probe
Locations (4)
Arizona Liver Health
Chandler, Arizona, United States
Hospital Padre Hurtrado
Santiago, Chile
Norfolk and Norwich Hospital
Norwich, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom