The Utility of Breath Biopsy as a Screening Tool for HCC

Cirrhosis, Liver Clinical Trial

— BrtH-C  

Official title:

The Utility of Breath Biopsy as a Screening Tool for HCC: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326491
• Other study ID #: 1-085-18
• Status: Completed
• Start date: June 20, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2022
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• HCC
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Breath Biopsy
Analysis of breath samples to identify volatile molecules specific to HCC

Locations

Country	Name	City	State
United Kingdom	Ashis Mukhopadhya	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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