Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

May 5, 2013 updated by: Thorsten Walles, Schillerhoehe Hospital

Distinction Between Lung Cancer and Gynecological Cancers by Exhalation Analysis and Canine Scent Detection

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Gerlingen, Baden-Württemberg, Germany, 70839
        • Schillerhoehe Hospital
      • Stuttgart, Baden-Württemberg, Germany, 70376
        • Robert Bosch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity for Lung Cancer
Time Frame: breath samples will be tested within 40 days after gathering
exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with lung cancer from those of patients with other (tested) cancers
breath samples will be tested within 40 days after gathering

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discriminability of breast and ovarian cancer
Time Frame: breath samples will be tested within 40 days after gathering
exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with breast cancer from those of patients with other ovarian cancer
breath samples will be tested within 40 days after gathering

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schillerhoehe Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 5, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH-TCH-IIT-2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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