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

Schillerhoehe Hospital

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Airway Disease; Lung Cancer

Treatments: Procedure: exhalation analysis of breath sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01141842

KSH-TCH-IIT-2010-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18-80
• competent
• confirmed lung cancer

Exclusion criteria

• history of other cancers

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 3 patient groups

lung cancer

Experimental group

Description:

breath samples of patients with confirmed lung cancer

Treatment:

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample

underlying lung disease

Active Comparator group

Description:

patients with underlying lung disease and impairment in lung function

Treatment:

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample

healthy individual

Sham Comparator group

Description:

healthy individual with no lung disease and no history of cancer including lung cancer

Treatment:

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample

Procedure: exhalation analysis of breath sample