Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
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.
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 COPD
- 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 COPD 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 Design
Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic
Conditions
Lung Cancer
Intervention
exhalation analysis of breath sample, exhalation analysis of breath sample, exhalation analysis of breath sample
Location
Schillerhoehe Hospital
Gerlingen
Germany
70839
Status
Completed
Source
Schillerhoehe Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01141842
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:01:02-0400
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