ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

HREC/11/QRBW/471

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Larynx Cancer

Condition category

Condition code

Cancer

Head and neck

Respiratory

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Difference in breath test signal for diagnosis

Timepoint [1]

12 months

Secondary outcome [1]

Individual VOCs identified by MSGC

Timepoint [1]

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?

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

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane and Womens Hospital - Brisbane

Recruitment postcode(s) [1]

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

David I Fielding, FRACP MD

Address

Royal Brisbane and Womens Hospital

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01700647