The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study

An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck

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)

Study Overview

• Status: Unknown
• Conditions: Head and Neck Squamous Cell Carcinoma; Human Papillomavirus

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Dana Middleton; Phone Number: 61 7 3176 3219; Email: dana.middleton@health.qld.gov.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
      • Principal Investigator: Ben Panizza, Assoc Prof
      • Principal Investigator: Sandro Porceddu, Assoc Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• nil

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify exposures associated with an increased risk of head and neck squamous cell carcinoma	2 years

Other Outcome Measures

Outcome Measure	Time Frame
To compare subjects who have ever been exposed with those who have never been exposed.	2 years
To estimate the effect of each exposure adjusted for the confounding effects of other exposures.	2 years
To test for trends in head and neck squamous cell carcinoma	2 years

Collaborators and Investigators

• Sponsor: Queensland Centre of Excellence for Head and Neck Cancer
• Collaborators: The University of Queensland; Princess Alexandra Hospital, Brisbane, Australia; QIMR Berghofer Medical Research Institute; Translational Research Institute, Brisbane, Australia
• Investigators: Principal Investigator: Annika Antonsson, Dr, QIMR Berghofer Medical Research Institute; Principal Investigator: Ben Panizza, Assoc Prof, Princess Alexandra Hospital; Principal Investigator: Sandro Porceddu, Assoc Prof, Princess Alexandra Hospital; Principal Investigator: David Whiteman, Prof, QIMR Berghofer Medical Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 27, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: risk factors; prevalence; Head and Neck Squamous Cell Carcinoma; Human Papillomavirus; clinical outcome; Aetiology
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: HREC13QPAH36