Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

Suspended

• Conditions: Oropharyngeal Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

• Registration Number: NCT02156180
• Lead Sponsor: Queensland Centre of Excellence for Head and Neck Cancer

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 13

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinoma	Approximately 1-4 months	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

Trial Locations

Locations (1)

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia