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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141842
• Other study ID #: KSH-TCH-IIT-2010-1
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2010
• Last updated: May 6, 2013
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2013
• Source: Schillerhoehe Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18-80

• competent

• confirmed lung cancer

Exclusion Criteria:

• history of other cancers

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Obstructive Airway Disease
• Lung Cancer
• Lung Diseases, Obstructive
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube
• exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube
• exhalation analysis of breath sample
breath sample is presented to sniffer dog in test tube

Locations

Country	Name	City	State
Germany	Schillerhoehe Hospital	Gerlingen
Germany	Praxis Heimann & Ehmann	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Schillerhoehe Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Boedeker E, Friedel G, Walles T. Sniffer dogs as part of a bimodal bionic research approach to develop a lung cancer screening. Interact Cardiovasc Thorac Surg. 2012 May;14(5):511-5. doi: 10.1093/icvts/ivr070. Epub 2012 Feb 17. Review. — View Citation

Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer	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	baseline	No
Secondary	absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer	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	baseline	No