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Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02156180
Enrollment
13
Registered
2014-06-05
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma

Keywords

exhaled breath, volatile organic compounds, surgery, chemotherapy, radiotherapy

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinomaApproximately 1-4 monthsBreath 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026