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

Phase 1

Completed

• Conditions: Lung Cancer; Chronic Obstructive Airway Disease
• Interventions: Procedure: exhalation analysis of breath sample

• Registration Number: NCT01141842
• Lead Sponsor: Schillerhoehe Hospital

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• age 18-80
• competent
• confirmed lung cancer

Exclusion Criteria

• history of other cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lung cancer	exhalation analysis of breath sample	breath samples of patients with confirmed lung cancer
underlying lung disease	exhalation analysis of breath sample	patients with underlying lung disease and impairment in lung function
healthy individual	exhalation analysis of breath sample	healthy individual with no lung disease and no history of cancer including lung cancer

Primary Outcome Measures

Name	Time	Method
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer	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

Secondary Outcome Measures

Name	Time	Method
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer	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

Trial Locations

Locations (2)

Schillerhoehe Hospital; 🇩🇪 Gerlingen, Germany

Praxis Heimann & Ehmann; 🇩🇪 Stuttgart, Germany