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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thorsten Walles, Schillerhoehe Hospital
ClinicalTrials.gov Identifier:
NCT01141842
First received: May 11, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Chronic Obstructive Airway Disease
Procedure: exhalation analysis of breath sample
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Schillerhoehe Hospital:

Primary Outcome Measures:
  • presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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:
  • absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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


Enrollment: 230
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lung cancer
breath samples of patients with confirmed lung cancer
Procedure: exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube
Active Comparator: underlying lung disease
patients with underlying lung disease and impairment in lung function
Procedure: exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube
Sham Comparator: healthy individual
healthy individual with no lung disease and no history of cancer including lung cancer
Procedure: exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-80
  • competent
  • confirmed lung cancer

Exclusion Criteria:

  • history of other cancers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141842

Locations
Germany
Schillerhoehe Hospital
Gerlingen, Germany, 70839
Praxis Heimann & Ehmann
Stuttgart, Germany, 70178
Sponsors and Collaborators
Schillerhoehe Hospital
Investigators
Principal Investigator: Thorsten Walles, MD Schillerhoehe Hospital
  More Information

Publications:
Responsible Party: Thorsten Walles, Principal Investigator, Schillerhoehe Hospital
ClinicalTrials.gov Identifier: NCT01141842     History of Changes
Other Study ID Numbers: KSH-TCH-IIT-2010-1
Study First Received: May 11, 2010
Last Updated: May 6, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Schillerhoehe Hospital:
lung cancer
exhalation analysis
chronic obstructive pulmonary disease
cancer screening test

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014