Cirrhosis, LiverDELIVERNCT07035158
DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis
An observational study of Cirrhosis, Liver, run by Owlstone Ltd at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Libra Oral Solution
- Type of treatment
- Pill or oral medicine
- How many people
- 190 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 May 2024to 29 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects that have a clinical suspicion or diagnosis of cirrhosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Norfolk and Norwich Hospital
Norwich, NR4 7UQ
Peterborough City Hospital
Peterborough, PE3 9GZ
About this study
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
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
Read the detailed description
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.
- Conditions
- Cirrhosis, Liver
- Being tested
- Libra Oral Solution
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libra Oral SolutionDiagnostic test
EVOC Probe
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Libra Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (3)
Sensitivity Analysis
Perform sensitivity analysis of the risk model for different cirrhosis etiology, and clinical characteristics
Measured: 10 months
Definition of the optimal breath collection method and timepoints
Define the test: Select optimal breath collection method and timepoint(s). An optimal test protocol is identified balancing diagnostic accuracy and acceptability of the breath test protocol to healthcare providers and patients
Measured: 10 months
Correlation of Risk Score
Correlation of risk score with existing tests and methods used to evaluate liver fibrosis stage, if available. Using established diagnostic approaches and risk scores including but not limited to Child Pugh score, MELD, UKELD, FIB4, APRI, liver biopsy parameters, liver stiffness and liver fat, signs of portal hypertension, fibrosis scoring, GGT, ALP, and their individual parameters.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start10 May 2024
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arun Shankar, Principal investigator, Norfolk & Norwich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035158
- Sponsor's protocol ID
- DEL001
- Acronym
- DELIVER
- Status last verified
- Jul 2026
- First submitted
- 21 May 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07035158
- Acronym / sponsor ID
- DELIVER / DEL001
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVOC probe | – | Diagnostic Test: Libra Oral SolutionAfter 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects that have a clinical suspicion or diagnosis of cirrhosis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Libra Oral SolutionEVOC Probe | Diagnostic test | EVOC probe |
Primary outcome
Developing a model to determine the risk of the presence of liver cirrhosis.
Time frame: 10 months
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.
3 secondary outcomes
Sensitivity Analysis
Time frame: 10 months
Definition of the optimal breath collection method and timepoints
Time frame: 10 months
Correlation of Risk Score
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Shankar principal investigator
Norfolk & Norwich University Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver, run by Owlstone Ltd at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, United States, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing a model to determine the risk of the presence of liver cirrhosis. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.