Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

NCT ID: NCT01383408

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Breast Cancer Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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healthy individual

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

Group Type SHAM_COMPARATOR

exhalation analysis of breath sample

Intervention Type OTHER

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

lung cancer

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

Group Type EXPERIMENTAL

exhalation analysis of breath sample

Intervention Type OTHER

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

breast cancer

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

Group Type EXPERIMENTAL

exhalation analysis of breath sample

Intervention Type OTHER

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

ovarian cancer

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

Group Type EXPERIMENTAL

exhalation analysis of breath sample

Intervention Type OTHER

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

Interventions

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exhalation analysis of breath sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role collaborator

Schillerhoehe Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thorsten Walles

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thorsten Walles, MD

Role: PRINCIPAL_INVESTIGATOR

Schillerhoehe Hospital

Godehard Friedel, MD

Role: STUDY_CHAIR

Schillerhoehe Hospital

Wolfgang Simon, MD

Role: STUDY_CHAIR

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Locations

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Schillerhoehe Hospital

Gerlingen, Baden-Wurttemberg, Germany

Site Status

Robert Bosch Hospital

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22345057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21852337 (View on PubMed)

Other Identifiers

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KSH-TCH-IIT-2011-1

Identifier Type: -

Identifier Source: org_study_id

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