Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02156180




Registration number
NCT02156180
Ethics application status
Date submitted
3/06/2014
Date registered
5/06/2014
Date last updated
22/04/2015

Titles & IDs
Public title
Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
HREC14QPAH10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Cavity Squamous Cell Carcinoma 0 0
Oropharyngeal Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Early stage oral cavity / oropharyngeal cancer - Exhaled breath
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinoma
Timepoint [1] 0 0
Approximately 1-4 months

Eligibility
Key inclusion criteria
* Age 18-90 years
* Clinical diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of metastatic disease
* Previous treatment of this cancer with surgery, chemotherapy or radiotherapy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2015
Actual
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre of Excellence for Head and Neck Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Queensland Health Forensic and Scientific Services
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02156180
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jae Lim, Dr
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02156180