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Clinical Trials/NCT04326491
NCT04326491
Completed
N/A

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

University of Aberdeen1 site in 1 country18 target enrollmentJune 20, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
HCC
Sponsor
University of Aberdeen
Enrollment
18
Locations
1
Primary Endpoint
Volatile organic compounds specific to HCC
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 20, 2021
End Date
May 16, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Volatile organic compounds specific to HCC

Time Frame: 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

Study Sites (1)

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