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Breath Testing in Early and Late Larynx Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700647
First Posted: October 4, 2012
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royal Brisbane and Women's Hospital
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: Breath Testing in Laryngeal Cancer- Comparing in Situ Cancer and Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Royal Brisbane and Women's Hospital:

Primary Outcome Measures:
  • Difference in breath test signal for diagnosis [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures:
  • Individual VOCs identified by MSGC [ Time Frame: 12 months ]
    Samples of breath will be analysed for differences in abundance of individual VOCs


Other Outcome Measures:
  • Separation of VOC profile of CIS versus advanced cancer [ Time Frame: 2 years ]
    THis separation may be less than that seen for Maholobonis distance between controls and either early or advanced cancer; if this is the case that would still be a positive outcome


Biospecimen Retention:   None Retained
Breath test- for analysis in ENose as well as massspectroscopy gas chromatography

Enrollment: 30
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at risk for larynx cancer
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700647


Locations
Australia, Queensland
Royal Brisbane and Womens Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Royal Brisbane and Women's Hospital
Investigators
Principal Investigator: David I Fielding, FRACP MD Royal Brisbane and Womens Hospital
  More Information

Publications:
Responsible Party: Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier: NCT01700647     History of Changes
Other Study ID Numbers: HREC/11/QRBW/471
First Submitted: October 2, 2012
First Posted: October 4, 2012
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Royal Brisbane and Women's Hospital:
Larynx cancer
Volatile organic compounds
Diagnosis
Bronchoscopy
Cancer staging

Additional relevant MeSH terms:
Laryngeal Diseases
Laryngeal Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms