Lung CancerNCT02759679
Canine-Assisted Profiling of Lung Cancer From Human Breath
A study testing Human breath samples in people with Lung Cancer, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Human breath samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers, lung cancer or other lung disease.
Who cannot join
- Other known malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes.
- Conditions
- Lung Cancer
- Being tested
- Human breath samples
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human breath samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Other | Patients with lung cancer Receives: Other: Human breath samples |
| Controls | Other | Controls being either healthy or having other lung disease Receives: Other: Human breath samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for lung cancer, of canines sniffing breath samples
Patients and Controls deliver breath samples to be presented for dogs in a Remote facility. Outcomes will be reported for individual dogs and combinations of dogs.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Fløtten, MD, Principal investigator, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759679
- Sponsor's protocol ID
- REK_2013/2053
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2016
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine-Assisted Profiling of Lung Cancer From Human Breath
- ClinicalTrials.gov ID
- NCT02759679
- Acronym / sponsor ID
- REK_2013/2053
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 May 2016 (estimated)
- 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 study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | Other | Other: Human breath samplesPatients with lung cancer |
| Controls | Other | Other: Human breath samplesControls being either healthy or having other lung disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers, lung cancer or other lung disease.
Key exclusion criteria (1 listed)
- Other known malignancy.
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 |
|---|---|---|
| Human breath samples | Other | Controls, Lung cancer |
Primary outcome
Sensitivity and specificity for lung cancer, of canines sniffing breath samples
Time frame: 2 years
Patients and Controls deliver breath samples to be presented for dogs in a Remote facility. Outcomes will be reported for individual dogs and combinations of dogs.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Øystein Fløtten, MD principal investigator
Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human breath samples in people with Lung Cancer, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Mar 2024. 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 Norway. 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 was stopped early. Results are not available in the source record.
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?
Sensitivity and specificity for lung cancer, of canines sniffing breath samples (time frame: 2 years). 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 1 Mar 2024.