The Utility of Breath Biopsy as a Screening Tool for HCC

NCT04326491 | Completed DMC

• 1 other identifier: 1-085-18
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.

Conditions

HCC; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Volatile organic compounds specific to HCC

  Quantitative analysis of the volume and pattern of volatile compounds in the breath of the individuals with HCC compared to that in the breath of individuals without HCC but with the same underlying disease

  6 months

Study Arms (2)

HCC

Participants are diagnosed with HCC on top of cirrhosis

Diagnostic Test: Breath Biopsy

Cirrhosis with no HCC

Participants are diagnosed with cirrhosis but have no HCC

Diagnostic Test: Breath Biopsy

Interventions

Breath Biopsy DIAGNOSTIC_TEST

Analysis of breath samples to identify volatile molecules specific to HCC

Cirrhosis with no HCC; HCC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is open for participants with liver Cirrhosis (without HCC allocated to an arm) and (with HCC allocated to the other arm). There is no gender restriction.

You may qualify if:

• Cirrhotic patients with HC.
• Cirrhotic patients without HCC

You may not qualify if:

• Patients with more than one primary cancer (HCC in addition to other cancer)
• Patients who are not aware of the diagnosis
• Patients in whom the diagnosis of HCC is not clear and only suspected
• Patients with severe chronic obstructive pulmonary disease (COPD) or severe asthma.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Ashis Mukhopadhya

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Bekheit, PhD

  NHS Grampian

  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: March 24, 2020
• First Posted: March 30, 2020
• Study Start: June 20, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

GB (1)