Volatile Organic Compounds for the Assessment of Liver Disease

NCT04620538 | Completed

• 1 other identifier: 19SM5129
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether a breath test could be used for early detection of hepatic fibrosis, cirrhosis or hepatocellular carcinoma. Patients who are attending for a planned liver outpatient services or investigations will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between fibrosis, cirrhosis and hepatocellular carcinoma.

Conditions

Cirrhosis; Cirrhosis, Liver; Fibrosis, Liver; Hepatocellular Carcinoma; Hepatocellular Cancer

Keywords

Volatile Organic Compound; VOC; Cirrhosis; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine the diagnostic accuracy of breath test for detection of fibrosis, cirrhosis or hepatocellular carcinoma.

  Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of fibrosis / cirrhosis / hepatocellular carcinoma. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.

  24 months

Study Arms (5)

Controls

Healthy Controls with or without risk factors for Chronic Liver Disease (i.e. patients referred due to concerns re: liver disease but found to have no evidence of chronic liver disease following assessment)

Diagnostic Test: Breath Analysis

Fibrosis

Patients with evidence of Liver Fibrosis on the basis of current diagnostic techniques / expert opinion.

Diagnostic Test: Breath Analysis

Compensated Cirrhosis

Patients with evidence of Compensated Cirrhosis on the basis of current diagnostic techniques / expert opinion.

Diagnostic Test: Breath Analysis

Decompensated Cirrhosis

Patients with evidence of Decompensated Cirrhosis on the basis of current diagnostic techniques / expert opinion.

Diagnostic Test: Breath Analysis

Hepatocellular Carcinoma

Patients with evidence of Hepatocellular Carcinoma on the basis of current diagnostic techniques / expert opinion.

Diagnostic Test: Breath Analysis

Interventions

Breath Analysis DIAGNOSTIC_TEST

Participants will be asked to provide 500mls of exhaled breath which will be loaded on to thermal desorption tubes and analysed via Mass Spectrometry.

Compensated Cirrhosis; Controls; Decompensated Cirrhosis; Fibrosis; Hepatocellular Carcinoma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified and recruited from Imperial College Healthcare NHS Trust inpatient admissions, routine outpatient hepatobiliary clinics, the radiology departments (e.g. for patients undergoing liver biopsy or imaging of their liver) and endoscopy units (e.g. liver disease patients undergoing endoscopic surveillance for varices). Patients with hepatocellular carcinoma may also be recruited from oncology outpatient clinics.

You may qualify if:

• Patients seen in secondary care with suspected or confirmed liver / pancreatic disease or hepatocellular carcinoma / pancreatic cancer

You may not qualify if:

• Patients who lack capacity or unable to provide informed consent.
• Any patient outside the established age range (18-90years).
• Patients unable to fast.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare Trust

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breath VOCs sampled on adsorbent tubes will be analysed within 48 hours of collection. The sample constituents are destroyed within the mass spectrometer for detection meaning that no clinical material will remain after analysis by the mass spectrometry instruments. Urine samples will be stored within a registered tissue bank (REC Ref no. 04/Q0403/119, custodian Prof G Hanna) in accordance with the Human Tissue Act and disposed of following analysis.

MeSH Terms

Conditions

Fibrosis; Liver Cirrhosis; Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• George B Hanna, FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: April 1, 2021
• Primary Completion: March 25, 2026
• Study Completion: March 26, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)