Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
Condition: Lung Cancer; Chronic Obstructive Airway Disease
MeSH terms: Lung Neoplasms; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): exhalation analysis of breath sample; exhalation analysis of breath sample; exhalation analysis of breath sample
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): breath sample is presented to sniffer dog in test tube; breath sample is presented to sniffer dog in test tube; breath sample is presented to sniffer dog in test tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: lung cancer; exhalation analysis; chronic obstructive pulmonary disease; cancer screening test