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/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
Scientific title
An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck
Secondary ID [1] 0 0
HREC13QPAH36
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Human Papillomavirus 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
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To identify exposures associated with an increased risk of head and neck squamous cell carcinoma
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* nil

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2016
Actual
Sample size
Target
600
Accrual to date
Final
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
QIMR Berghofer Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Translational Research Institute, Brisbane, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The University of Queensland
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/study/NCT02126189
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Annika Antonsson, Dr
Address 0 0
QIMR Berghofer Medical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dana Middleton
Address 0 0
Country 0 0
Phone 0 0
61 7 3176 3219
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02126189