Lung CancerPhase 2NCT01383408
Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection
A Phase 2 study testing exhalation analysis of breath sample in people with Lung Cancer and Breast Cancer, run by Schillerhoehe Hospital at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Breast Cancer, Ovarian Cancer
- What is being tested?
- exhalation analysis of breath sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 752 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically confirmed lung or breast or ovarian cancer
Who cannot join
- other cancers
- previous medical intervention within the last 14 days before gathering of the breath sample
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Schillerhoehe Hospital
Gerlingen, Baden-Wurttemberg, 70839
Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, 70376
About this study
Official title: 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.
- Conditions
- Lung Cancer, Breast Cancer, Ovarian Cancer
- Being tested
- exhalation analysis of breath sample
- Keywords
- breath sample analysis, exhalation analysis, volatile organic compounds, screening, lung cancer, breast cancer, ovarian cancer, canine scent detection
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhalation analysis of breath sampleOther
study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis
| Study group | Role | What they receive |
|---|---|---|
| healthy individual | Sham comparator | healthy individual with no lung disease and no history of cancer including lung cancer Receives: Other: exhalation analysis of breath sample |
| lung cancer | Experimental | patients with histologically confirmed lung cancer, but no history of other cancer Receives: Other: exhalation analysis of breath sample |
| breast cancer | Experimental | patients with histologically confirmed breast cancer, but no history of other cancer Receives: Other: exhalation analysis of breath sample |
| ovarian cancer | Experimental | patients with histologically confirmed ovarian cancer, but no history of other cancer Receives: Other: exhalation analysis of breath sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: breath samples will be tested within 40 days after gathering
Secondary outcomes (1)
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
Measured: breath samples will be tested within 40 days after gathering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Inconsistent training status of sniffer dogs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schillerhoehe Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Responsible party
- Principal investigator, Thorsten Walles, Schillerhoehe Hospital
- Investigators
- Thorsten Walles, MD, Principal investigator, Schillerhoehe HospitalGodehard Friedel, MD, Study chair, Schillerhoehe HospitalWolfgang Simon, MD, Study chair, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383408
- Sponsor's protocol ID
- KSH-TCH-IIT-2011-1
- Status last verified
- May 2013
- First submitted
- 24 Jun 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22345057Ehmann 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.
PubMed 21852337
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinction Between Lung Cancer and Gynecological Cancers by Exhalation Analysis and Canine Scent Detection
- ClinicalTrials.gov ID
- NCT01383408
- Acronym / sponsor ID
- KSH-TCH-IIT-2011-1
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inconsistent training status of sniffer dogs
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Schillerhoehe HospitalUniversity, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy individual | Sham comparator | Other: exhalation analysis of breath samplehealthy individual with no lung disease and no history of cancer including lung cancer |
| lung cancer | Experimental | Other: exhalation analysis of breath samplepatients with histologically confirmed lung cancer, but no history of other cancer |
| breast cancer | Experimental | Other: exhalation analysis of breath samplepatients with histologically confirmed breast cancer, but no history of other cancer |
| ovarian cancer | Experimental | Other: exhalation analysis of breath samplepatients with histologically confirmed ovarian cancer, but no history of other cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically confirmed lung or breast or ovarian cancer
Key exclusion criteria (2 listed)
- other cancers
- previous medical intervention within the last 14 days before gathering of the breath sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exhalation analysis of breath samplestudy participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis | Other | breast cancer, healthy individual, lung cancer, ovarian cancer |
Primary outcome
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
1 secondary outcome
Discriminability of breast and ovarian cancer
Time frame: breath samples will be tested within 40 days after gathering
Results and safety
The study was stopped early (reason given: Inconsistent training status of sniffer dogs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Background: PubMed 22345057Boedeker 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.
- Background: PubMed 21852337Ehmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Walles, MD principal investigator
Schillerhoehe Hospital
Godehard Friedel, MD study chair
Schillerhoehe Hospital
Wolfgang Simon, MD study chair
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exhalation analysis of breath sample in people with Lung Cancer and Breast Cancer, run by Schillerhoehe Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inconsistent training status of sniffer dogs). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity for Lung Cancer (time frame: breath samples will be tested within 40 days after gathering). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.