Head and Neck Squamous Cell CarcinomaNCT02126189
The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study
An observational study of Head and Neck Squamous Cell Carcinoma and Human Papillomavirus, run by Queensland Centre of Excellence for Head and Neck Cancer at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Human Papillomavirus
- How many people
- 600 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Ben Panizza, Assoc Prof
Sandro Porceddu, Assoc Prof
About this study
Official title: 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)
Read the 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.
- Keywords
- Head and Neck Squamous Cell Carcinoma, Human Papillomavirus, Aetiology, prevalence, risk factors, clinical outcome
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To identify exposures associated with an increased risk of head and neck squamous cell carcinoma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre of Excellence for Head and Neck Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- QIMR Berghofer Medical Research Institute, Princess Alexandra Hospital, Brisbane, Australia, Translational Research Institute, Brisbane, Australia, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Annika Antonsson, Dr, Principal investigator, QIMR Berghofer Medical Research InstituteBen Panizza, Assoc Prof, Principal investigator, Princess Alexandra HospitalSandro Porceddu, Assoc Prof, Principal investigator, Princess Alexandra HospitalDavid Whiteman, Prof, Principal investigator, QIMR Berghofer Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126189
- Sponsor's protocol ID
- HREC13QPAH36
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2014
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study of Mucosal Squamous Cell Carcinomas of the Head and Neck
- ClinicalTrials.gov ID
- NCT02126189
- Acronym / sponsor ID
- HREC13QPAH36
- Keywords
- Head and Neck Squamous Cell Carcinoma, Human Papillomavirus, Aetiology, prevalence, risk factors, clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Queensland Centre of Excellence for Head and Neck CancerUniversity, hospital or other
- Collaborators
- QIMR Berghofer Medical Research Institute, Princess Alexandra Hospital, Brisbane, Australia, Translational Research Institute, Brisbane, Australia, The University of Queensland
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify exposures associated with an increased risk of head and neck squamous cell carcinoma
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika Antonsson, Dr principal investigator
QIMR Berghofer Medical Research Institute
Ben Panizza, Assoc Prof principal investigator
Princess Alexandra Hospital
Sandro Porceddu, Assoc Prof principal investigator
Princess Alexandra Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma and Human Papillomavirus, run by Queensland Centre of Excellence for Head and Neck Cancer at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Middleton (61 7 3176 3219, dana.middleton@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify exposures associated with an increased risk of head and neck squamous cell carcinoma (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.