Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

Sponsor
Queensland Centre of Excellence for Head and Neck Cancer (Other)
Overall Status
Suspended
CT.gov ID
NCT02156180
Collaborator
Princess Alexandra Hospital, Brisbane, Australia (Other), Queensland Health Forensic and Scientific Services (Other)
13
1
12
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 Start Date :
    Apr 1, 2014
    Anticipated Primary Completion Date :
    Apr 1, 2015
    Anticipated Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Early stage oral cavity / oropharyngeal cancer

    Exhaled breath

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Alexandra Hospital Brisbane Queensland Australia 4102

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jae Lim, Dr, Princess Alexandra Hospital
    • Principal Investigator: Ben Panizza, Assoc Prof, Princess Alexandra Hospital
    • Principal Investigator: Vince Alberts, Mr, Queensland Health Forensic and Scientific Services
    • Principal Investigator: Jeff Herse, Mr, Queensland Health Forensic and Scientific Services
    • Principal Investigator: David Pass, Mr, Queensland Health Forensic and Scientific Services
    • Principal Investigator: Nigel Brown, Dr, Princess Alexandra Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Queensland Centre of Excellence for Head and Neck Cancer
    ClinicalTrials.gov Identifier:
    NCT02156180
    Other Study ID Numbers:
    • HREC14QPAH10
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Apr 22, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Queensland Centre of Excellence for Head and Neck Cancer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2015