Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02156180
• Other study ID #: HREC14QPAH10
• Status: Suspended
• Phase: N/A
• First received: June 3, 2014
• Last updated: April 20, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Queensland Centre of Excellence for Head and Neck Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 13
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Cavity Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Queensland Centre of Excellence for Head and Neck Cancer	Princess Alexandra Hospital, Brisbane, Australia, Queensland Health Forensic and Scientific Services

Country where clinical trial is conducted

Australia, 

References & Publications (5)

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. Review. — View 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. Review. — View Citation

Döbrossy L. Epidemiology of head and neck cancer: magnitude of the problem. Cancer Metastasis Rev. 2005 Jan;24(1):9-17. Review. — View Citation

Lippi G. Re: Jean-Nicolas Cornu,Géraldine Cancel-Tassin, Valérie 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinoma	Breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma will be compared before treatment - surgery or radiotherapy/chemotherapy, and then one month after completion of treatment - surgery or radiotherapy/chemotherapy	Approximately 1-4 months	No