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NCT Number: NCT01141842

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

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.

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Key information

Conditions

Lung Cancer Chronic Disease Chronic Obstructive Airway Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Schillerhoehe Hospital, Gerlingen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-80
  • competent
  • confirmed lung cancer

Exclusion criteria

  • history of other cancers

Treatment and study plan

exhalation analysis of breath sample

Procedure

breath sample is presented to sniffer dog in test tube

Primary outcomes

  1. presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer

    Time frame: 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 outcomes

  1. absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Schillerhoehe Hospital

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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