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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Arizona
Arizona Liver Health
RECRUITING
Chandler
Other Locations
Chile
Hospital Padre Hurtrado
RECRUITING
Santiago
United Kingdom
Norfolk and Norwich Hospital
RECRUITING
Norwich
Peterborough City Hospital
RECRUITING
Peterborough
Contact Information
Primary
Chloe Ms Bartlett
chloe.bartlett@owlstone.co.uk
+ 44 07821 655984
Backup
Liz Ms Thompson
deliverstudy@owlstone.co.uk
+447821 654139
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 240
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Owlstone Ltd

This content was sourced from clinicaltrials.gov