NCT01383408

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

June 24, 2011

Last Update Submit

May 5, 2013

Conditions

Lung CancerBreast CancerOvarian Cancer

Keywords

breath sample analysisexhalation analysisvolatile organic compoundsscreeninglung cancerbreast cancerovarian cancercanine scent detection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Discriminability of breast and ovarian cancer

    breath samples will be tested within 40 days after gathering

Study Arms (4)

healthy individual

SHAM COMPARATOR

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

Other: exhalation analysis of breath sample

lung cancer

EXPERIMENTAL

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

Other: exhalation analysis of breath sample

breast cancer

EXPERIMENTAL

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

Other: exhalation analysis of breath sample

ovarian cancer

EXPERIMENTAL

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

Other: exhalation analysis of breath sample

Interventions

exhalation analysis of breath sampleOTHER

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

breast cancerhealthy individuallung cancerovarian cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed lung or breast or ovarian cancer

You may not qualify if:

  • other cancers
  • previous medical intervention within the last 14 days before gathering of the breath sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Schillerhoehe Hospital

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

Robert Bosch Hospital

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Related 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.

    PMID: 22345057BACKGROUND

  • 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.

    PMID: 21852337BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Thorsten Walles, MD

    Schillerhoehe Hospital

    PRINCIPAL INVESTIGATOR

  • Godehard Friedel, MD

    Schillerhoehe Hospital

    STUDY CHAIR

  • Wolfgang Simon, MD

    Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 28, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

DE(2)