HCCBrtH-CNCT04326491
The Utility of Breath Biopsy as a Screening Tool for HCC
An observational study of HCC and Cirrhosis, Liver, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC, Cirrhosis, Liver
- What is being tested?
- Breath Biopsy
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2021to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cirrhotic patients with HC.
- Cirrhotic patients without HCC
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- HCC, Cirrhosis, Liver
- Being tested
- Breath Biopsy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath BiopsyDiagnostic test
Analysis of breath samples to identify volatile molecules specific to HCC
| Study group | Role | What they receive |
|---|---|---|
| HCC | Participants are diagnosed with HCC on top of cirrhosis Receives: Diagnostic Test: Breath Biopsy | |
| Cirrhosis with no HCC | Participants are diagnosed with cirrhosis but have no HCC Receives: Diagnostic Test: Breath Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile organic compounds specific to HCC
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start20 Jun 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Bekheit, PhD, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326491
- Sponsor's protocol ID
- 1-085-18
- Acronym
- BrtH-C
- Status last verified
- May 2022
- First submitted
- 24 Mar 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Breath Biopsy as a Screening Tool for HCC: A Pilot Study
- ClinicalTrials.gov ID
- NCT04326491
- Acronym / sponsor ID
- BrtH-C / 1-085-18
- Conditions
- HCC, Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC | – | Diagnostic Test: Breath BiopsyParticipants are diagnosed with HCC on top of cirrhosis |
| Cirrhosis with no HCC | – | Diagnostic Test: Breath BiopsyParticipants are diagnosed with cirrhosis but have no HCC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cirrhotic patients with HC.
- Cirrhotic patients without HCC
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath BiopsyAnalysis of breath samples to identify volatile molecules specific to HCC | Diagnostic test | Cirrhosis with no HCC, HCC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Bekheit, PhD principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Cirrhosis, Liver, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile organic compounds specific to HCC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.