Clinical trial NCT02126189: The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study
Official title: An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Human Papillomavirus
Keywords: Head and Neck Squamous Cell Carcinoma
Human Papillomavirus
Aetiology
prevalence
risk factors
clinical outcome
Lead sponsor: Queensland Centre of Excellence for Head and Neck Cancer
Sponsor class: OTHER
Collaborators: name: QIMR Berghofer Medical Research Institute
name: Princess Alexandra Hospital, Brisbane, Australia
name: Translational Research Institute, Brisbane, Australia
name: The University of Queensland
First posted: 2014-04-29
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital, Brisbane, Australia. Patients may be be new patients or old patients and may have a new diagnosis or they may have a recurrence.

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)

Detailed description: Data is collected using a simple four-page paper-based questionnaire. Information to be collected include age, sex, height and weight (at age 20, current age, and heaviest ever), history of cancer (own and partner). Questions about recreational physical activity, smoking history and alcohol consumption, acid reflux, heartburn, denture use and tonsillectomy, frequency of use of paracetamol, antihistamine and NSAIDS.

The questionnaires also ask participants some detailed questions about sexual behaviour and history if they are comfortable to give this information.

Eligibility criteria: Inclusion Criteria:

* All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.

Exclusion Criteria:

* nil

Primary outcomes:
measure: To identify exposures associated with an increased risk of head and neck squamous cell carcinoma
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: To compare subjects who have ever been exposed with those who have never been exposed.
timeFrame: 2 years
measure: To estimate the effect of each exposure adjusted for the confounding effects of other exposures.
timeFrame: 2 years
measure: To test for trends in head and neck squamous cell carcinoma
timeFrame: 2 years
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: QIMR Berghofer Medical Research Institute
name: Annika Antonsson, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Alexandra Hospital
name: Ben Panizza, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Alexandra Hospital
name: Sandro Porceddu, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: QIMR Berghofer Medical Research Institute
name: David Whiteman, Prof
role: PRINCIPAL_INVESTIGATOR
References: