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DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

NCT07035158 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-09-03

No results posted yet for this 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

Conditions

  • Cirrhosis, Liver

Interventions

DIAGNOSTIC_TEST

Libra Oral Solution

EVOC Probe

Sponsors & Collaborators

  • Owlstone Ltd

    lead INDUSTRY

Principal Investigators

  • Arun Shankar · Norfolk & Norwich University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States
  • Chile
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035158 on ClinicalTrials.gov