Back to resultsCanine-Assisted Profiling of Lung Cancer From Human Breath
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Human breath samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion criteria:
Healthy volunteers, lung cancer or other lung disease.
Exclusion criteria:
Other known malignancy.
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lung cancer
Controls
Arm Description
Patients with lung cancer
Controls being either healthy or having other lung disease
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02759679
First Posted
March 17, 2016
Last Updated
February 6, 2019
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02759679
Brief Title
Canine-Assisted Profiling of Lung Cancer From Human Breath
Official Title
Canine-Assisted Profiling of Lung Cancer From Human Breath
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung cancer
Arm Type
Other
Arm Description
Patients with lung cancer
Arm Title
Controls
Arm Type
Other
Arm Description
Controls being either healthy or having other lung disease
Intervention Type
Other
Intervention Name(s)
Human breath samples
Primary Outcome Measure Information:
Title
Sensitivity and specificity for lung cancer, of canines sniffing breath samples
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy volunteers, lung cancer or other lung disease.
Exclusion criteria:
Other known malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Fløtten, MD
Organizational Affiliation
Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Canine-Assisted Profiling of Lung Cancer From Human Breath
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