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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
Scientific title
Breath Testing in Laryngeal Cancer- Comparing in Situ Cancer and Advanced Cancer
Secondary ID [1] 0 0
HREC/11/QRBW/471
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Larynx Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in breath test signal for diagnosis
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Individual VOCs identified by MSGC
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* those with known larynx cancer (either in situ or advanced)
* patients with smoking history referred for bronchoscopy or laryngoscopy
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* other solid tumours
* inability to undergo bronchoscopy/laryngoscopy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Womens Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
Royal Brisbane and Women's Hospital
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01700647
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.
Public notes

Contacts
Principal investigator
Name 0 0
David I Fielding, FRACP MD
Address 0 0
Royal Brisbane and Womens Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01700647