Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
May 6, 2013 updated by: Thorsten Walles, Schillerhoehe Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gerlingen, Germany, 70839
- Schillerhoehe Hospital
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Stuttgart, Germany, 70178
- Praxis Heimann & Ehmann
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-80
- competent
- confirmed lung cancer
Exclusion Criteria:
- history of other cancers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: healthy individual
healthy individual with no lung disease and no history of cancer including lung cancer
|
breath sample is presented to sniffer dog in test tube
|
|
Experimental: lung cancer
breath samples of patients with confirmed lung cancer
|
breath sample is presented to sniffer dog in test tube
|
|
Active Comparator: underlying lung disease
patients with underlying lung disease and impairment in lung function
|
breath sample is presented to sniffer dog in test tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
Time Frame: baseline
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
Time Frame: baseline
|
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
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thorsten Walles, MD, Schillerhoehe Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 11, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
May 7, 2013
Last Update Submitted That Met QC Criteria
May 6, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSH-TCH-IIT-2010-1
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