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

NCT02126189 | Unknown

• 1 other identifier: HREC13QPAH36
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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)

Conditions

Head and Neck Squamous Cell Carcinoma; Human Papillomavirus

Keywords

Head and Neck Squamous Cell Carcinoma; Human Papillomavirus; Aetiology; prevalence; risk factors; clinical outcome

Outcome Measures

Primary Outcomes (1)

• To identify exposures associated with an increased risk of head and neck squamous cell carcinoma

  2 years

Other Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• nil

Sponsors & Collaborators

• Queensland Centre of Excellence for Head and Neck Cancer: lead
• QIMR Berghofer Medical Research Institute: collaborator
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Translational Research Institute, Brisbane, Australia: collaborator
• The University of Queensland: collaborator

Study Sites (1)

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Participants are asked to give their consent for researchers to obtain tissue from tumour blocks. This tissue is taken as part of their normal care and treatment. If consent is given, formalin-fixed paraffin embedded (FFPE) tissue samples will be used to determine HPV status.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Middleton

CONTACT

61 7 3176 3219; dana.middleton@health.qld.gov.au

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

AU (1)