DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

NCT07035158 | Recruiting

• 1 other identifier: DEL001
• Study Type: observational
• Target: 240
• Locations: 3 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Developing a model to determine the risk of the presence of liver cirrhosis.

  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.

  10 months

Secondary Outcomes (3)

• Sensitivity Analysis

  10 months

• Definition of the optimal breath collection method and timepoints

  10 months

• Correlation of Risk Score

  10 months

Study Arms (1)

EVOC probe

After confirming full eligibility, the EVOC probe will be administered orally to both cases (individuals with cirrhosis) and controls (individuals with a clinical suspicion of cirrhosis)

Diagnostic Test: Libra Oral Solution

Interventions

Libra Oral Solution DIAGNOSTIC_TEST

EVOC Probe

EVOC probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects that have a clinical suspicion or diagnosis of cirrhosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Owlstone Ltd: lead

Study Sites (4)

Arizona Liver Health

Chandler, Arizona, 85224, United States

RECRUITING

Hospital Padre Hurtrado

Santiago, Chile

RECRUITING

Norfolk and Norwich Hospital

Norwich, NR4 7UQ, United Kingdom

RECRUITING

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun Shankar

  Norfolk & Norwich University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Ms Bartlett

CONTACT

+ 44 07821 655984; chloe.bartlett@owlstone.co.uk

Liz Ms Thompson

CONTACT

+447821 654139; deliverstudy@owlstone.co.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 24, 2025
• Study Start: May 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); US (1); GB (2)