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The Utility of Breath Biopsy as a Screening Tool for HCC (BrtH-C)

U

University of Aberdeen

Status

Completed

Conditions

Cirrhosis, Liver
HCC

Treatments

Diagnostic Test: Breath Biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT04326491
1-085-18

Details and patient eligibility

About

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.

Full 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

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

18 participants in 2 patient groups

HCC
Description:
Participants are diagnosed with HCC on top of cirrhosis
Treatment:
Diagnostic Test: Breath Biopsy
Cirrhosis with no HCC
Description:
Participants are diagnosed with cirrhosis but have no HCC
Treatment:
Diagnostic Test: Breath Biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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