Breath Testing in Early and Late Larynx Cancer

NCT01700647 | Completed DMC

• 1 other identifier: HREC/11/QRBW/471
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Larynx Cancer

Keywords

Larynx cancer; Volatile organic compounds; Diagnosis; Bronchoscopy; Cancer staging

Outcome Measures

Primary Outcomes (1)

• Difference in breath test signal for diagnosis

  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.

  12 months

Secondary Outcomes (1)

• Individual VOCs identified by MSGC

  12 months

Other Outcomes (1)

• Separation of VOC profile of CIS versus advanced cancer

  2 years

Study Arms (3)

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; Other: Laryngoscopy and bronchoscopy

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; Other: Laryngoscopy and bronchoscopy

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; Other: Laryngoscopy and bronchoscopy

Interventions

Breath test- sampling using ENose OTHER

Patients give a sample of breath ( slow vital capacity breath, collected in Tedlar bag and immediately analysed and discarded)

Advanced Larynx Cancer; In Situ carcinoma larynx; smoking controls

Laryngoscopy and bronchoscopy OTHER

Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.

Advanced Larynx Cancer; In Situ carcinoma larynx; smoking controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk for larynx cancer

You may qualify if:

• those with known larynx cancer (either in situ or advanced)
• patients with smoking history referred for bronchoscopy or laryngoscopy

You may not qualify if:

• other solid tumours
• inability to undergo bronchoscopy/laryngoscopy

Sponsors & Collaborators

• Royal Brisbane and Women's Hospital: lead

Study Sites (1)

Royal Brisbane and Womens Hospital

Brisbane, Queensland, 4029, Australia

Location

Related Publications (1)

• 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.

  PMID: 21505455 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Breath test- for analysis in ENose as well as massspectroscopy gas chromatography

MeSH Terms

Conditions

Laryngeal Neoplasms; Disease

Interventions

Laryngoscopy; Bronchoscopy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• David I Fielding, FRACP MD

  Royal Brisbane and Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

AU (1)