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

NCT01141842 | Completed Phase 1

• 1 other identifier: KSH-TCH-IIT-2010-1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Chronic Obstructive Airway Disease

Keywords

lung cancer; exhalation analysis; chronic obstructive pulmonary disease; cancer screening test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  baseline

Study Arms (3)

lung cancer

EXPERIMENTAL

breath samples of patients with confirmed lung cancer

Procedure: exhalation analysis of breath sample

underlying lung disease

ACTIVE COMPARATOR

patients with underlying lung disease and impairment in lung function

Procedure: exhalation analysis of breath sample

healthy individual

SHAM COMPARATOR

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

Procedure: exhalation analysis of breath sample

Interventions

exhalation analysis of breath sample PROCEDURE

breath sample is presented to sniffer dog in test tube

lung cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80
• competent
• confirmed lung cancer

You may not qualify if:

• history of other cancers

Sponsors & Collaborators

• Schillerhoehe Hospital: lead

Study Sites (2)

Schillerhoehe Hospital

Gerlingen, 70839, Germany

Location

Praxis Heimann & Ehmann

Stuttgart, 70178, Germany

Location

Related 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.

  PMID: 22345057 BACKGROUND

• 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.

  PMID: 21852337 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Thorsten Walles, MD

  Schillerhoehe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: June 11, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

DE (2)