Clinical trial NCT02156180: Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma
Official title: A Prospective Cohort Study to Determine Specific Volatile Organic Compounds Present in Breath Samples of Patients With Oral Cavity or Oropharyngeal Squamous Cell Carcinoma Using Gas Chromotography-mass Spectrometry
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Oral Cavity Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
Keywords: exhaled breath
volatile organic compounds
surgery
chemotherapy
radiotherapy
Lead sponsor: Queensland Centre of Excellence for Head and Neck Cancer
Sponsor class: OTHER
Collaborators: name: Princess Alexandra Hospital, Brisbane, Australia
name: Queensland Health Forensic and Scientific Services
First posted: 2014-06-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who attend the Head and Neck Cancer Clinic at the Princess Alexandra Hospital, Brisbane, Australia

Brief summary: In this study the Investigators aim to determine specific volatile compounds present in breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before and after tumour resection or before and after chemotherapy +/- radiotherapy using gas chromotography-mass spectrometry. The Investigators hypothesize that study participants with a tumour will display a distinct set of volatile organic compounds than can serve as potential cancer biomarkers.

Detailed description: Head and neck cancer diagnosis is devastating as it frequently disrupts one's ability to communicate, swallow and breathe. Each year, physicians diagnose approximately 650,000 cases of head and neck cancer worldwide. Many people with head and neck cancer have their cancer detected late, and this can result in a poor clinical outcome. One strategy to improve the clinical outcomes for people with a head and neck cancer is to develop a non-invasive screening assay using breath biomarkers. Such a diagnostic tool will identify at-risk individuals early, and potentially offer improved and cost-effective treatment.

The idea of using human breath samples to detect cancer began with the observation that dogs can be trained to "sniff out" certain types of cancers from urine and blood. Since then the presence of various volatile organic compounds from many types of cancers, including: lung, skin, breast, prostate, and bladder have been characterized. These studies are ongoing, but promise to revolutionize the way physicians screen cancer in the future.

In this pilot study, the Investigators aim to determine specific volatile organic compounds present in breath samples of patients with oral cavity or oropharyngeal cancer before and after tumor resection, or before and after definitive chemotherapy/radiotherapy. As head and neck cancer can result in significant functional deficit, early detection is the key to improving clinical outcome. Much anecdotal evidence exists for the presence of distinct odor emissions from the tumor bed of head and neck cancer patients. Therefore, the identification of specific volatile organic compound to head and neck cancer will undoubtedly lead to a novel, cost-effective screening strategy for early detection of head and neck cancer.

Eligibility criteria: Inclusion Criteria:

* Age 18-90 years
* Clinical diagnosis of oral cavity or oropharyngeal squamous cell carcinoma

Exclusion Criteria:

* Evidence of metastatic disease
* Previous treatment of this cancer with surgery, chemotherapy or radiotherapy

Primary outcomes:
measure: Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinoma
timeFrame: Approximately 1-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: Princess Alexandra Hospital
name: Jae Lim, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Alexandra Hospital
name: Ben Panizza, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Health Forensic and Scientific Services
name: Vince Alberts, Mr
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Health Forensic and Scientific Services
name: Jeff Herse, Mr
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Health Forensic and Scientific Services
name: David Pass, Mr
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Alexandra Hospital
name: Nigel Brown, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willis CM, Church SM, Guest CM, Cook WA, McCarthy N, Bransbury AJ, Church MR, Church JC. Olfactory detection of human bladder cancer by dogs: proof of principle study. BMJ. 2004 Sep 25;329(7468):712. doi: 10.1136/bmj.329.7468.712.
citation: Chan HP, Lewis C, Thomas PS. Exhaled breath analysis: novel approach for early detection of lung cancer. Lung Cancer. 2009 Feb;63(2):164-8. doi: 10.1016/j.lungcan.2008.05.020. Epub 2008 Jul 2.
citation: Lippi G. Re: Jean-Nicolas Cornu,Geraldine Cancel-Tassin, Valerie Ondet, et Al. Olfactory detection of prostate cancer by dogs sniffing urine: a step forward in early diagnosis. Eur urol 2011; 59: 197-201. Eur Urol. 2011 Oct;60(4):e29; author reply e30. doi: 10.1016/j.eururo.2011.06.030. Epub 2011 Jun 22. No abstract available.
citation: Badjagbo K. Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques. Clin Chem Lab Med. 2012 Nov;50(11):1893-1902. doi: 10.1515/cclm-2012-0208.
citation: Dobrossy L. Epidemiology of head and neck cancer: magnitude of the problem. Cancer Metastasis Rev. 2005 Jan;24(1):9-17. doi: 10.1007/s10555-005-5044-4.