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Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

Primary Purpose

Lung Cancer, Breast Cancer, Ovarian Cancer

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

exhalation analysis of breath sample

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring breath sample analysis, exhalation analysis, volatile organic compounds, screening, lung cancer, breast cancer, ovarian cancer, canine scent detection

Eligibility Criteria

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

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

Sites / Locations

Schillerhoehe Hospital
Robert Bosch Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Arm Label

healthy individual

lung cancer

breast cancer

ovarian cancer

Arm Description

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

patients with histologically confirmed lung cancer, but no history of other cancer

patients with histologically confirmed breast cancer, but no history of other cancer

patients with histologically confirmed ovarian cancer, but no history of other cancer

Outcomes

Primary Outcome Measures

Specificity for Lung Cancer

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

exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with breast cancer from those of patients with other ovarian cancer

Full Information

NCT ID

NCT01383408

First Posted

June 24, 2011

Last Updated

May 5, 2013

Sponsor

Schillerhoehe Hospital

Collaborators

Robert Bosch Gesellschaft für Medizinische Forschung mbH

1. Study Identification

Unique Protocol Identification Number

NCT01383408

Brief Title

Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Terminated

Why Stopped

Inconsistent training status of sniffer dogs

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Schillerhoehe Hospital

Collaborators

Robert Bosch Gesellschaft für Medizinische Forschung mbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Breast Cancer, Ovarian Cancer

Keywords

breath sample analysis, exhalation analysis, volatile organic compounds, screening, lung cancer, breast cancer, ovarian cancer, canine scent detection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

752 (Actual)

8. Arms, Groups, and Interventions

Arm Title

healthy individual

Arm Type

Sham Comparator

Arm Description

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

Arm Title

lung cancer

Arm Type

Experimental

Arm Description

patients with histologically confirmed lung cancer, but no history of other cancer

Arm Title

breast cancer

Arm Type

Experimental

Arm Description

patients with histologically confirmed breast cancer, but no history of other cancer

Arm Title

ovarian cancer

Arm Type

Experimental

Arm Description

patients with histologically confirmed ovarian cancer, but no history of other cancer

Intervention Type

Other

Intervention Name(s)

exhalation analysis of breath sample

Intervention Description

study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis

Primary Outcome Measure Information:

Title

Specificity for Lung Cancer

Description

exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with lung cancer from those of patients with other (tested) cancers

Time Frame

breath samples will be tested within 40 days after gathering

Secondary Outcome Measure Information:

Title

Discriminability of breast and ovarian cancer

Description

exhalation analysis by sniffer dogs is able to differentiate breath samples of patients with breast cancer from those of patients with other ovarian cancer

Time Frame

breath samples will be tested within 40 days after gathering

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thorsten Walles, MD

Organizational Affiliation

Schillerhoehe Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Godehard Friedel, MD

Organizational Affiliation

Schillerhoehe Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wolfgang Simon, MD

Organizational Affiliation

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Official's Role

Study Chair

Facility Information:

Facility Name

Schillerhoehe Hospital

City

Gerlingen

State/Province

Baden-Württemberg

ZIP/Postal Code

70839

Country

Germany

Facility Name

Robert Bosch Hospital

City

Stuttgart

State/Province

Baden-Württemberg

ZIP/Postal Code

70376

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

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Learn more about this trial

Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

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