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RECRUITING
NCT07035158

DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

Sponsor: Owlstone Ltd

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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