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Completed

NCT Number: NCT04326491

The Utility of Breath Biopsy as a Screening Tool for HCC

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ashis Mukhopadhya

Aberdeen, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath Biopsy

Diagnostic Test

Analysis of breath samples to identify volatile molecules specific to HCC

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

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

Acronym: BrtH-C

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2020
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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