Lung CancerPhase 1NCT01141842
Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity
A Phase 1 study testing exhalation analysis of breath sample in people with Lung Cancer and Chronic Obstructive Airway Disease, run by Schillerhoehe Hospital at 2 sites in Germany.
Trial summary
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). 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, Chronic Obstructive Airway Disease
- What is being tested?
- exhalation analysis of breath sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 1
- 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
- age 18-80
- competent
- confirmed lung cancer
Who cannot join
- history of other cancers
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Schillerhoehe Hospital
Gerlingen, 70839
Praxis Heimann & Ehmann
Stuttgart, 70178
About this study
Official title: Prospective Clinical Study to Determine the Predictive Value of Sniffer Dogs to Identify Lung Cancer in the Exhalation of Patients With and Without Pulmonary Disease
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.
Read the detailed description
All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
Three study groups are defined using the following inclusion and exclusion criteria:
- lung cancer: male \& female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
- healthy individual: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
- chronic obstructive lung disease: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
- 5 BS are presented in 1 experiment:
- Test I: lung cancer vs healthy individual
- Test II: lung cancer vs chronic obstructive pulmonary disease
- Test III: lung cancer vs healthy individuals \& bronchitis
- for every experiment 1 BS of a lung cancer patient is used
- the lung cancer sample is placed randomly in one of the five test tubes
- the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
- neither the dog handler nor the dog know the loading of the test tubes
- experiments are repeated 5 to 10 times
For analysis, the sensitivity and specificity of the dog's reaction is determined.
The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.
- Conditions
- Lung Cancer, Chronic Obstructive Airway Disease
- Being tested
- exhalation analysis of breath sample
- Keywords
- lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhalation analysis of breath sampleProcedure or surgery
breath sample is presented to sniffer dog in test tube
exhalation analysis of breath sampleProcedure or surgery
breath sample is presented to sniffer dog in test tube
exhalation analysis of breath sampleProcedure or surgery
breath sample is presented to sniffer dog in test tube
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | Experimental | breath samples of patients with confirmed lung cancer Receives: Procedure: exhalation analysis of breath sample |
| underlying lung disease | Active comparator | patients with underlying lung disease and impairment in lung function Receives: Procedure: exhalation analysis of breath sample |
| healthy individual | Sham comparator | healthy individual with no lung disease and no history of cancer including lung cancer Receives: Procedure: exhalation analysis of breath sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer
Measured: baseline
Secondary outcomes (1)
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
number of individuals with confirmed impairment of lung function but exclusion of lung cancer whose exhalation sample is wrongly identified by sniffer dogs to contain a heretofore unknown substrate that is associated with lung cancer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schillerhoehe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorsten Walles, Schillerhoehe Hospital
- Investigators
- Thorsten Walles, MD, Principal investigator, Schillerhoehe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141842
- Sponsor's protocol ID
- KSH-TCH-IIT-2010-1
- Status last verified
- May 2013
- First submitted
- 11 May 2010
- 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
- Prospective Clinical Study to Determine the Predictive Value of Sniffer Dogs to Identify Lung Cancer in the Exhalation of Patients With and Without Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01141842
- Acronym / sponsor ID
- KSH-TCH-IIT-2010-1
- Conditions
- Lung Cancer, Chronic Obstructive Airway Disease
- Keywords
- lung cancer, exhalation analysis, chronic obstructive pulmonary disease, cancer screening test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Schillerhoehe HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2010 (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.
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.
Detailed description
All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
Three study groups are defined using the following inclusion and exclusion criteria:
- lung cancer: male \& female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
- healthy individual: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
- chronic obstructive lung disease: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
- 5 BS are presented in 1 experiment:
- Test I: lung cancer vs healthy individual
- Test II: lung cancer vs chronic obstructive pulmonary disease
- Test III: lung cancer vs healthy individuals \& bronchitis
- for every experiment 1 BS of a lung cancer patient is used
- the lung cancer sample is placed randomly in one of the five test tubes
- the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
- neither the dog handler nor the dog know the loading of the test tubes
- experiments are repeated 5 to 10 times
For analysis, the sensitivity and specificity of the dog's reaction is determined.
The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lung cancer | Experimental | Procedure: exhalation analysis of breath samplebreath samples of patients with confirmed lung cancer |
| underlying lung disease | Active comparator | Procedure: exhalation analysis of breath samplepatients with underlying lung disease and impairment in lung function |
| healthy individual | Sham comparator | Procedure: exhalation analysis of breath samplehealthy individual with no lung disease and no history of cancer including lung cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-80
- competent
- confirmed lung cancer
Key exclusion criteria (1 listed)
- history of other cancers
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 samplebreath sample is presented to sniffer dog in test tube | Procedure or surgery | lung cancer |
| exhalation analysis of breath samplebreath sample is presented to sniffer dog in test tube | Procedure or surgery | underlying lung disease |
| exhalation analysis of breath samplebreath sample is presented to sniffer dog in test tube | Procedure or surgery | healthy individual |
Primary outcome
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
Time frame: baseline
number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer
1 secondary outcome
absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
- Results publication: 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exhalation analysis of breath sample in people with Lung Cancer and Chronic Obstructive Airway Disease, 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 3 inclusion and 1 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: finished, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer (time frame: baseline). 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 NCT01141842, 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.