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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02126189
Registration number
NCT02126189
Ethics application status
Date submitted
23/04/2014
Date registered
29/04/2014
Date last updated
22/04/2015
Titles & IDs
Public title
The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study
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Scientific title
An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck
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Secondary ID [1]
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HREC13QPAH36
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma
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Human Papillomavirus
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Head and neck cancer - All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital, Brisbane, Australia are invited to participate.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To identify exposures associated with an increased risk of head and neck squamous cell carcinoma
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Assessment method [1]
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Timepoint [1]
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2 years
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Eligibility
Key inclusion criteria
* All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* nil
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2016
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Queensland Centre of Excellence for Head and Neck Cancer
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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QIMR Berghofer Medical Research Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Translational Research Institute, Brisbane, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The University of Queensland
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to refine the aetiological causes of cancers of the head and neck and investigate the ways in which human papillomavirus and life-style factors cause head and neck cancers. This study will determine if these factors affect the treatment of cancer. All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited to complete a risk factor questionnaire and give consent for their clinical data and tissue samples to be available for future research activities. The risk factor questionnaire is based on existing validated instruments developed by the QIMR Berghofer Medical Research Institute Cancer Control Group, and will collect standardised information relating to demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition, asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity, diet quality etc) and behaviours (oral sex etc)
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Trial website
https://clinicaltrials.gov/study/NCT02126189
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Annika Antonsson, Dr
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Address
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QIMR Berghofer Medical Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dana Middleton
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Address
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Country
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Phone
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61 7 3176 3219
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Fax
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Email
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[email protected]
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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/NCT02126189
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