Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01383408
• Other study ID #: KSH-TCH-IIT-2011-1
• Status: Terminated
• Phase: Phase 2
• First received: June 24, 2011
• Last updated: May 5, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Schillerhoehe Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 752
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Lung Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• exhalation analysis of breath sample
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis

Locations

Country	Name	City	State
Germany	Schillerhoehe Hospital	Gerlingen	Baden-Württemberg
Germany	Robert Bosch Hospital	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Schillerhoehe Hospital	Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

References & 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	breath samples will be tested within 40 days after gathering	No
Secondary	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	breath samples will be tested within 40 days after gathering	No