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

May 16, 2022 updated by: University of Aberdeen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study is open for participants with liver Cirrhosis (without HCC allocated to an arm) and (with HCC allocated to the other arm). There is no gender restriction.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC
Participants are diagnosed with HCC on top of cirrhosis
Diagnostic test: Breath Biopsy
Analysis of breath samples to identify volatile molecules specific to HCC
Cirrhosis with no HCC
Participants are diagnosed with cirrhosis but have no HCC
Diagnostic test: Breath Biopsy
Analysis of breath samples to identify volatile molecules specific to HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Mohamed Bekheit, PhD, NHS Grampian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-085-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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