Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Cancer, Chronic Obstructive Airway Disease

Intervention / Treatment
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* Procedure: exhalation analysis of breath sample
* Procedure: exhalation analysis of breath sample
* Procedure: exhalation analysis of breath sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 competent confirmed lung cancer Exclusion Criteria: history of other cancers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lung cancer<br>breath samples of patients with confirmed lung cancer | Procedure: exhalation analysis of breath sample<br>* breath sample is presented to sniffer dog in test tube<br>|
| Active Comparator: underlying lung disease<br>patients with underlying lung disease and impairment in lung function | Procedure: exhalation analysis of breath sample<br>* breath sample is presented to sniffer dog in test tube<br>|
| Sham Comparator: healthy individual<br>healthy individual with no lung disease and no history of cancer including lung cancer | Procedure: exhalation analysis of breath sample<br>* breath sample is presented to sniffer dog in test tube<br>|

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test