Clinical Trial: Breath Testing in Laryngeal Cancer

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Breath Testing in Laryngeal Cancer- Comparing in Situ Cancer and Advanced Cancer

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

Detailed Summary:

Worldwide there are 130 000 new larnx cancers diagnosed annually resulting in 82 000 deaths [1].Survival after diagnosis of larynx cancer depends on initial stage. For T3N0Mo laryngeal cancers 5-year survival ranges from 59 to 66%. Patients survivals are as follows: receiving either chemoradiation (59.2%), irradiation alone (42.7%) ,patients after surgery with irradiation (65.2%) and surgery alone (63.3%) [2] By contrast in early stage larynx cancer survivals range from 90-100%. Tamura et al reported therapeutic outcomes of 130 cases with laryngeal cancer treated at Kyoto University Hospital between 1995 and 2004[3] In all, 121 males and 9 females were involved. Their ages ranged from 40 years to 92 years (average 66 years). All tumors were squamous cell carcinoma - arising at the glottis in 111 cases, the supraglottis in 18, and the subglottis in 1 case. Most glottic cancers (77.5%) were classified as stage I or II, while most supraglottic cancers (77.8%) were at stage III or IV. Stage I/II cancers were basically treated by conventional radiotherapy (60-66 Gy) and twice-daily hyperfractionated radiotherapy (70-74 Gy), respectively, attempting to preserve the larynx. Total laryngectomy with neck dissection was performed in the treatment of stage III/IV cases. Five-year disease-specific survival rates were 100%, 96%, 100%, and 68% for stage I, II, III, and IV, respectively. Five-year laryngeal preservation rates were 98%, 100%, 86%, 0%, and 0% for T1a, T1b, T2, T3, and T4 of glottic cancer, respectively. Local recurrence occurred in five cases of stage I/II glottic cancer, which was successfully salvaged.

Chera et al [4] reported excellent treatment outcomes of definitive radiotherapy (RT) for early-stage squamous cell carcinoma (SCCA) of the glottic larynx. The median follow-up for survivors was 12 years. Five-year Local Control rates were as follows: T1A, 94%; T1B, 93%;
Sponsor: Royal Brisbane and Women's Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome: Individual VOCs identified by MSGC [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Royal Brisbane and Women's Hospital

Dates:
Date Received: October 2, 2012
Date Started: October 2012
Date Completion: October 2013
Last Updated: October 2, 2012
Last Verified: October 2012