Breath Testing in Laryngeal Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Larynx Cancer |
Other: Breath test- sampling using ENose Other: Laryngoscopy and bronchoscopy |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Breath Testing in Laryngeal Cancer- Comparing in Situ Cancer and Advanced Cancer |
- Difference in breath test signal for diagnosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Individual VOCs identified by MSGC [ Time Frame: 12 months ] [ Designated as safety issue: No ]Samples of breath will be analysed for differences in abundance of individual VOCs
Biospecimen Retention: None Retained
Breath test- for analysis in ENose as well as massspectroscopy gas chromatography
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Other: 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: Laryngoscopy and bronchoscopy
Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.
|
|
In Situ carcinoma larynx
Biopsy proven in situ carcinoma larynx proven by laryngoscopy and bronchoscopy Breath test- sampling using ENose
|
Other: 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: Laryngoscopy and bronchoscopy
Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.
|
|
Advanced Larynx Cancer
Biopsy proven stage 3/4 larynx cancer proven by laryngoscopy and bronchoscopy Breath test- sampling using ENose
|
Other: 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: Laryngoscopy and bronchoscopy
Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients at risk for larynx cancer
Inclusion Criteria:
- those with known larynx cancer (either in situ or advanced)
- patients with smoking history referred for bronchoscopy or laryngoscopy
Exclusion Criteria:
- other solid tumours
- inability to undergo bronchoscopy/laryngoscopy
Contacts and Locations| Australia, Queensland | |
| Royal Brisbane and Womens Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Principal Investigator: | David I Fielding, FRACP MD | Royal Brisbane and Womens Hospital |
More Information
No publications provided
| Responsible Party: | Royal Brisbane and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01700647 History of Changes |
| Other Study ID Numbers: | HREC/11/QRBW/471 |
| Study First Received: | October 2, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Royal Brisbane and Women's Hospital:
|
Larynx cancer Volatile organic compounds Diagnosis Bronchoscopy Cancer staging |
Additional relevant MeSH terms:
|
Laryngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013