The Utility of Breath Biopsy as a Screening Tool for HCC

NCT ID: NCT04326491

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-20

Study Completion Date

2022-05-16

Brief Summary

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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

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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

Conditions

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HCC Cirrhosis, Liver

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC

Participants are diagnosed with HCC on top of cirrhosis

Breath Biopsy

Intervention Type DIAGNOSTIC_TEST

Analysis of breath samples to identify volatile molecules specific to HCC

Cirrhosis with no HCC

Participants are diagnosed with cirrhosis but have no HCC

Breath Biopsy

Intervention Type DIAGNOSTIC_TEST

Analysis of breath samples to identify volatile molecules specific to HCC

Interventions

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Breath Biopsy

Analysis of breath samples to identify volatile molecules specific to HCC

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Bekheit, PhD

Role: PRINCIPAL_INVESTIGATOR

NHS Grampian

Locations

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Ashis Mukhopadhya

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1-085-18

Identifier Type: -

Identifier Source: org_study_id

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