At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Libra Oral Solution (diagnostic test)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- Libra Oral Solution — diagnostic test: EVOC Probe
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 190
- Started
- 2024-05-10
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for cirrhosis, liver
- • Clinical study - 190 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cirrhosis, liver
Where?
- • Norwich - Norfolk and Norwich Hospital
- • Peterborough - Peterborough City Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
Liver disease and cirrhosis specifically is an area of growing public health concern with serious liver disease frequently presenting at advanced stages. Up to 75% of patients with cirrhosis receive their first diagnosis after they arrive at the accident and emergency department with a failing (decompensating) liver. This late diagnosis can lead to poor prognosis as treatments available are less effective at preserving the liver. At present early detection is difficult as early disease often has few or no symptoms, and current diagnostic methods are either invasive or have limited accuracy. There is therefore an unmet need for easy to use, non-invasive tests that can help to diagnose cirrhosis earlier, when treatments are still effective at preserving liver function and increasing life expectancy. A breath test may fulfil such requirements. The DELIVER study aims to develop a breath test that can identify cirrhosis at an earlier stage. Recent research has shown that cells inside the body produce substances that end up in the lungs and are breathed out, or 'exhaled' in breath. These studies have shown that those substances may be different if someone is suffering from a particular disease, including liver cirrhosis. Research has also shown that when we ingest a certain product (referred to as a 'probe') it may be processed differently in the body if you are healthy, compared to if you have a particular disease. This is very similar to different bodies digesting foods in different ways. This difference in processing leads to different types of chemicals being released by the body which would show up on breath as a sign of the presence or absence of disease.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥ 18 years.
- ✓Able to provide written agreement to take part.
- ✓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...
Who cannot take part
- ✗Interventional treatment for (underlying cause of) cirrhosis aimed at disease modification during the past six...
- ✗Received an investigational medicinal product in the context of a Clinical Trial (CTIMP) during the 28 days prior to...
- ✗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,...
- ✗Subjects on peritoneal- or hemo-dialysis
See the full criteria
Where Is This Study? (2 UK sites)
Norfolk and Norwich Hospital
Norwich NR4 7UQ, United Kingdom
Peterborough City Hospital
Peterborough PE3 9GZ, United Kingdom