The Utility of Breath Biopsy as a Screening Tool for HCC

Completed

• Conditions: HCC; Cirrhosis, Liver
• Interventions: Diagnostic Test: Breath Biopsy

• Registration Number: NCT04326491
• Lead Sponsor: University of Aberdeen

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.

Detailed Description

20 Participants will be included in the study. Ten Cirrhotic patients with HCC and 10 Cirrhotic patients without HCC.

The first group is patients with HCC secondary to cirrhosis. The second group will be patients with cirrhosis who are currently on the standard surveillance program with no HCC. Confirmation of the absence of HCC would have been ensured via a recent advanced imaging modality (dynamic CT scan or MRI) in the ongoing surveillance programme.

Participants will breathe into either a mouthpiece or collection tube then Breath samples will be analyzed via an analyzer to detect the volatile organic compounds (VOC) and quantitatively compare them

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Study Start: 2021-06-20
• Status Verified: 2022-05
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Cirrhotic patients with HC.
• Cirrhotic patients without HCC

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC	Breath Biopsy	Participants are diagnosed with HCC on top of cirrhosis
Cirrhosis with no HCC	Breath Biopsy	Participants are diagnosed with cirrhosis but have no HCC

Primary Outcome Measures

Name	Time	Method
Volatile organic compounds specific to HCC	6 months	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

Trial Locations

Locations (1)

Ashis Mukhopadhya; 🇬🇧 Aberdeen, United Kingdom