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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
Assessment method [1] 0 0
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
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Queensland Health Forensic and Scientific Services
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02156180