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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01700647
Registration number
NCT01700647
Ethics application status
Date submitted
2/10/2012
Date registered
4/10/2012
Date last updated
12/09/2017
Titles & IDs
Public title
Breath Testing in Early and Late Larynx Cancer
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Scientific title
Breath Testing in Laryngeal Cancer- Comparing in Situ Cancer and Advanced Cancer
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Secondary ID [1]
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HREC/11/QRBW/471
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Larynx Cancer
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Condition category
Condition code
Cancer
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Head and neck
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Breath test- sampling using ENose
Other interventions - Laryngoscopy and bronchoscopy
smoking controls - patients referred for bronchoscopy who have detailed axamination and do not have any dysplasia proven by bronchoscopy and laryngoscopy Breath test- sampling using ENose
In Situ carcinoma larynx - Biopsy proven in situ carcinoma larynx proven by laryngoscopy and bronchoscopy Breath test- sampling using ENose
Advanced Larynx Cancer - Biopsy proven stage 3/4 larynx cancer proven by laryngoscopy and bronchoscopy Breath test- sampling using ENose
Other interventions: Breath test- sampling using ENose
Patients give a sample of breath ( slow vital capacity breath, collected in Tedlar bag and immediately analysed and discarded)
Other interventions: Laryngoscopy and bronchoscopy
Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference in breath test signal for diagnosis
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Assessment method [1]
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Statistical differences can be obtained using software in the Enose- Mahlobinis distance after Principle component analysis of breath signals to separate controls from in situ cancer and from advanced cancer.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Individual VOCs identified by MSGC
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Assessment method [1]
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Samples of breath will be analysed for differences in abundance of individual VOCs
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Timepoint [1]
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12 months
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Eligibility
Key inclusion criteria
* those with known larynx cancer (either in situ or advanced)
* patients with smoking history referred for bronchoscopy or laryngoscopy
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* other solid tumours
* inability to undergo bronchoscopy/laryngoscopy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Womens Hospital - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Royal Brisbane and Women's Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
It is possible to test a sample of breath from a patient, run it through a machine, and find out certain diseases in the patient without needing to do Xrays. It is sort of like a"breathalyser".In the future it is hoped this type of testing will be common, and allow certain conditions to be picked up early. One of these conditions is Cancer of the Larynx (voice box). It is not in wide use yet however a study has shown it is very effective in detecting Larynx cancer. This breath test has detected cancers at a stage when they CAN be seen on Xrays or looking in with cameras. However the larger the cancer ultimately the worse it is for the patient. It would therefore be much better to have the breath test find patients with cancers at a much smaller size. It is interesting that the cancers which the breath test HAVE found all have the same breath test signal, regardless of size. This means even smaller cancers may have the same signal. These small cancers are only 1-2 mm thick, and when found at this size almost all can be cured. We want to find a group of patients who have these early cancers and compare it to breath test result in patients who have large obvious cancers. These patients will be compared to other patients who have are negative for larynx cancer who also have a breath test. We want to prove that their breath test will be negative. You have been referred either because you have symptoms (such as cough or hoarse voice) and need a scope to look into the airways, OR your specialist has identified a spot on the larynx which needs a biopsy (sample) and then possible treatment, The spot may or may not be cancer- that is why the biopsy is needed. After that the correct treatment would be considered depending on the result, that is, whether it is a cancer or not. If possible we would like to take a test of your breath before the biopsy. Alternatively we can take a breath test 2 weeks after a biopsy. In summary this study is trying to show whether the breath test is the same in patients who have large cancers as patients with small cancers invisible on XRay and only found with careful magnification by scopes looking in. If we can show these findings it will demonstrate great potential for the breath test to find many more cancers which are truly curable.
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Trial website
https://clinicaltrials.gov/study/NCT01700647
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Trial related presentations / publications
Hakim M, Billan S, Tisch U, Peng G, Dvrokind I, Marom O, Abdah-Bortnyak R, Kuten A, Haick H. Diagnosis of head-and-neck cancer from exhaled breath. Br J Cancer. 2011 May 10;104(10):1649-55. doi: 10.1038/bjc.2011.128. Epub 2011 Apr 19.
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Public notes
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Contacts
Principal investigator
Name
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David I Fielding, FRACP MD
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Address
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Royal Brisbane and Womens Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01700647
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