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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126189
• Other study ID #: HREC13QPAH36
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2014
• Last updated: April 20, 2015
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: April 2015
• Source: Queensland Centre of Excellence for Head and Neck Cancer
• Contact: Dana Middleton
• Phone: 61 7 3176 3219
• Email: dana.middleton[@]health.qld.gov.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Human Papillomavirus

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland

Sponsors (5)

Lead Sponsor	Collaborator
Queensland Centre of Excellence for Head and Neck Cancer	Princess Alexandra Hospital, Brisbane, Australia, QIMR Berghofer Medical Research Institute, The University of Queensland, Translational Research Institute, Brisbane, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To compare subjects who have ever been exposed with those who have never been exposed.		2 years	No
Other	To estimate the effect of each exposure adjusted for the confounding effects of other exposures.		2 years	No
Other	To test for trends in head and neck squamous cell carcinoma		2 years	No
Primary	To identify exposures associated with an increased risk of head and neck squamous cell carcinoma		2 years	No