Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
Primary Purpose
Lung Cancer, Chronic Obstructive Airway Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
exhalation analysis of breath sample
exhalation analysis of breath sample
exhalation analysis of breath sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test
Eligibility Criteria
Inclusion Criteria:
- age 18-80
- competent
- confirmed lung cancer
Exclusion Criteria:
- history of other cancers
Sites / Locations
- Schillerhoehe Hospital
- Praxis Heimann & Ehmann
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
lung cancer
underlying lung disease
healthy individual
Arm Description
breath samples of patients with confirmed lung cancer
patients with underlying lung disease and impairment in lung function
healthy individual with no lung disease and no history of cancer including lung cancer
Outcomes
Primary Outcome Measures
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer
Secondary Outcome Measures
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
number of individuals with confirmed impairment of lung function but exclusion of lung cancer whose exhalation sample is wrongly identified by sniffer dogs to contain a heretofore unknown substrate that is associated with lung cancer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01141842
Brief Title
Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
Official Title
Prospective Clinical Study to Determine the Predictive Value of Sniffer Dogs to Identify Lung Cancer in the Exhalation of Patients With and Without Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schillerhoehe Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.
Detailed Description
All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
Three study groups are defined using the following inclusion and exclusion criteria:
lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
5 BS are presented in 1 experiment:
Test I: lung cancer vs healthy individual
Test II: lung cancer vs chronic obstructive pulmonary disease
Test III: lung cancer vs healthy individuals & bronchitis
for every experiment 1 BS of a lung cancer patient is used
the lung cancer sample is placed randomly in one of the five test tubes
the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
neither the dog handler nor the dog know the loading of the test tubes
experiments are repeated 5 to 10 times
For analysis, the sensitivity and specificity of the dog's reaction is determined.
The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Chronic Obstructive Airway Disease
Keywords
lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lung cancer
Arm Type
Experimental
Arm Description
breath samples of patients with confirmed lung cancer
Arm Title
underlying lung disease
Arm Type
Active Comparator
Arm Description
patients with underlying lung disease and impairment in lung function
Arm Title
healthy individual
Arm Type
Sham Comparator
Arm Description
healthy individual with no lung disease and no history of cancer including lung cancer
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Primary Outcome Measure Information:
Title
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
Description
number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer
Time Frame
baseline
Secondary Outcome Measure Information:
Title
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
Description
number of individuals with confirmed impairment of lung function but exclusion of lung cancer whose exhalation sample is wrongly identified by sniffer dogs to contain a heretofore unknown substrate that is associated with lung cancer
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-80
competent
confirmed lung cancer
Exclusion Criteria:
history of other cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Walles, MD
Organizational Affiliation
Schillerhoehe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schillerhoehe Hospital
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Praxis Heimann & Ehmann
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22345057
Citation
Boedeker E, Friedel G, Walles T. Sniffer dogs as part of a bimodal bionic research approach to develop a lung cancer screening. Interact Cardiovasc Thorac Surg. 2012 May;14(5):511-5. doi: 10.1093/icvts/ivr070. Epub 2012 Feb 17.
Results Reference
background
PubMed Identifier
21852337
Citation
Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18.
Results Reference
result
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Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
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