RecruitingNCT07035158

DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

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

Sponsor

Owlstone Ltd

Enrollment

240 participants

Start Date

May 10, 2024

Study Type

OBSERVATIONAL

Conditions

Cirrhosis, Liver

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age ≥ 18 years.
Able to provide written informed consent.
Clinical suspicion of cirrhosis evaluated in the last six months preceding the recruitment into the study.
The presence of clinical suspicion is at the discretion of the (referring) clinician. For reference this will typically be based on (a combination of) the following:
Risk factors: viral hepatitis, metabolic dysfunction associated steatotic liver disease (MASLD), alcoholic liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, haemochromatosis or combinations of these diseases
Symptoms: e.g. fatigue, weakness, abdominal pain, nausea, vomiting, loss of appetite, oedema, jaundice, spider angioma, palmar erythema, clubbing, gastrointestinal bleeding or altered blood parameters in a liver function test.

Exclusion Criteria8

Interventional treatment for (underlying cause of) cirrhosis aimed at disease modification during the past six months. Any treatment solely focused on symptom/complications management are permissible.
Received an investigational medicinal product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe.
Women who are pregnant or breastfeeding, for women of childbearing potential a urine pregnancy test can be administered
Known allergy/intolerance to any of the constituents of the EVOC-probe cocktail, specifically limonene, 2-butanol, 2-pentanone, polysorbate 80 (aka Tween-80), and sucralose.
Subjects on peritoneal- or hemo-dialysis
Primary referral for evaluation of the presence of liver cancer (e.g. abnormal findings on imaging).
The presence of histopathologically diagnosed liver cancer.
(Anticipated) inability to complete the breath sampling procedure due to e.g., inability to maintain adequate ventilation unaided / Inability to comply with the study procedures in the opinion of the investigator.