Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT02156180

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early stage oral cavity / oropharyngeal cancer

Exhaled breath

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role: collaborator

Queensland Health Forensic and Scientific Services

UNKNOWN

Sponsor Role: collaborator

Queensland Centre of Excellence for Head and Neck Cancer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Lim, Dr

Role: PRINCIPAL_INVESTIGATOR

Princess Alexandra Hospital

Ben Panizza, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Princess Alexandra Hospital

Vince Alberts, Mr

Role: PRINCIPAL_INVESTIGATOR

Queensland Health Forensic and Scientific Services

Jeff Herse, Mr

Role: PRINCIPAL_INVESTIGATOR

Queensland Health Forensic and Scientific Services

David Pass, Mr

Role: PRINCIPAL_INVESTIGATOR

Queensland Health Forensic and Scientific Services

Nigel Brown, Dr

Role: PRINCIPAL_INVESTIGATOR

Princess Alexandra Hospital

Locations

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 15388612 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18599152 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21726935 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22718640 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15785869 (View on PubMed)

Other Identifiers

HREC14QPAH10

Identifier Type: -

Identifier Source: org_study_id