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

Primary Purpose

Lung Cancer, Chronic Obstructive Airway Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
exhalation analysis of breath sample
exhalation analysis of breath sample
exhalation analysis of breath sample
Sponsored by
Schillerhoehe Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-80
  • competent
  • confirmed lung cancer

Exclusion Criteria:

  • history of other cancers

Sites / Locations

  • Schillerhoehe Hospital
  • Praxis Heimann & Ehmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

lung cancer

underlying lung disease

healthy individual

Arm Description

breath samples of patients with confirmed lung cancer

patients with underlying lung disease and impairment in lung function

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2010
Last Updated
May 6, 2013
Sponsor
Schillerhoehe Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01141842
Brief Title
Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schillerhoehe Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Chronic Obstructive Airway Disease
Keywords
lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lung cancer
Arm Type
Experimental
Arm Description
breath samples of patients with confirmed lung cancer
Arm Title
underlying lung disease
Arm Type
Active Comparator
Arm Description
patients with underlying lung disease and impairment in lung function
Arm Title
healthy individual
Arm Type
Sham Comparator
Arm Description
healthy individual with no lung disease and no history of cancer including lung cancer
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Intervention Type
Procedure
Intervention Name(s)
exhalation analysis of breath sample
Intervention Description
breath sample is presented to sniffer dog in test tube
Primary Outcome Measure Information:
Title
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
Description
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
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-80 competent confirmed lung cancer Exclusion Criteria: history of other cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Walles, MD
Organizational Affiliation
Schillerhoehe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schillerhoehe Hospital
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Praxis Heimann & Ehmann
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22345057
Citation
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.
Results Reference
background
PubMed Identifier
21852337
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.
Results Reference
result

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

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