Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

This study has been terminated.
(Inconsistent training status of sniffer dogs)
Sponsor:
Collaborator:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Information provided by (Responsible Party):
Thorsten Walles, Schillerhoehe Hospital
ClinicalTrials.gov Identifier:
NCT01383408
First received: June 24, 2011
Last updated: May 5, 2013
Last verified: May 2013
  Purpose

Previous studies have shown that specially trained sniffer dogs are capable to discriminate breath samples of patients with lung cancer and healthy individuals. So far it is not known whether this differentiation is specific for lung cancer or just identifies any form of (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast cancer and ovarian cancer is tested.


Condition Intervention Phase
Lung Cancer
Breast Cancer
Ovarian Cancer
Other: exhalation analysis of breath sample
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Distinction Between Lung Cancer and Gynecological Cancers by Exhalation Analysis and Canine Scent Detection

Resource links provided by NLM:


Further study details as provided by Schillerhoehe Hospital:

Primary Outcome Measures:
  • Specificity for Lung Cancer [ Time Frame: breath samples will be tested within 40 days after gathering ] [ Designated as safety issue: No ]
    exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with lung cancer from those of patients with other (tested) cancers


Secondary Outcome Measures:
  • Discriminability of breast and ovarian cancer [ Time Frame: breath samples will be tested within 40 days after gathering ] [ Designated as safety issue: No ]
    exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with breast cancer from those of patients with other ovarian cancer


Enrollment: 752
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: healthy individual
healthy individual with no lung disease and no history of cancer including lung cancer
Other: exhalation analysis of breath sample
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis
Experimental: lung cancer
patients with histologically confirmed lung cancer, but no history of other cancer
Other: exhalation analysis of breath sample
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis
Experimental: breast cancer
patients with histologically confirmed breast cancer, but no history of other cancer
Other: exhalation analysis of breath sample
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis
Experimental: ovarian cancer
patients with histologically confirmed ovarian cancer, but no history of other cancer
Other: exhalation analysis of breath sample
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis

  Eligibility

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

Inclusion Criteria:

  • histologically confirmed lung or breast or ovarian cancer

Exclusion Criteria:

  • other cancers
  • previous medical intervention within the last 14 days before gathering of the breath sample
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383408

Locations
Germany
Schillerhoehe Hospital
Gerlingen, Baden-Württemberg, Germany, 70839
Robert Bosch Hospital
Stuttgart, Baden-Württemberg, Germany, 70376
Sponsors and Collaborators
Schillerhoehe Hospital
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Principal Investigator: Thorsten Walles, MD Schillerhoehe Hospital
Study Chair: Godehard Friedel, MD Schillerhoehe Hospital
Study Chair: Wolfgang Simon, MD Robert Bosch Gesellschaft für Medizinische Forschung mbH
  More Information

Publications:
Responsible Party: Thorsten Walles, Principal Investigator, Schillerhoehe Hospital
ClinicalTrials.gov Identifier: NCT01383408     History of Changes
Other Study ID Numbers: KSH-TCH-IIT-2011-1
Study First Received: June 24, 2011
Last Updated: May 5, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Schillerhoehe Hospital:
breath sample analysis
exhalation analysis
volatile organic compounds
screening
lung cancer
breast cancer
ovarian cancer
canine scent detection

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 17, 2014