Head and Neck CancerARCAGE-NWENCT02049177
Investigation of the Role of Human Papilloma Virus (HPV) in the Prognosis of Head and Neck Cancer
An observational study of Head and Neck Cancer, run by University of Aberdeen at 6 sites in United Kingdom.
Trial summary
Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important questions remain however, regarding the role of specific types of HPV, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 141 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Nov 2013to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases that were previously identified for the HPV-AHEAD case-control study.
Who may be able to join
- Consent to follow-up and use of tissue samples
Who cannot join
- No existing consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Royal Blackburn Hospital
Blackburn
Blackpool Victoria Infirmary
Blackpool
Manchester Royal Infirmary
Manchester
North Manchester General Hospital
Manchester
The Christie Hospital
Manchester
Royal Preston Hospital
Preston
About this study
Official title: Alcohol Related Cancers and Genetic Susceptibility in Europe Follow-up - North-West England
Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important questions remain however, regarding the role of specific types of HPV, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol), and potential geographical differences in the effect of HPV.
Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is an international collaboartive case-control study conducted in 15 centres in 11 European countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a systematic analysis of HPV subtypes known or suspected to be involved in head and neck cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx, hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by exposure to other known or suspected carcinogens including tobacco, alcohol and medical history.
It is intended that this work will contribute to the development of evidence that may feed into treatment protocols for these cancers as well as evaluations of the feasibility for extending HPV vaccine programs.
- Conditions
- Head and Neck Cancer
- Keywords
- Cancer, Epidemiology, Head and Neck, HPV
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
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 Cases | Cases of Head and Neck Cancer identified in North West England in 2002/2003. Observational study - no intervention other than usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV type
Measured: From surgical/biopsy samples taken in 2002/2003, to be typed in 2014
Secondary outcomes (3)
Vital status
Measured: 2014
Cancer Reccurrence
Measured: 2002-2014
Secondary cancers
Measured: 2002-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 only
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049177
- Sponsor's protocol ID
- 2/084/13
- Acronym
- ARCAGE-NWE
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Related Cancers and Genetic Susceptibility in Europe Follow-up - North-West England
- ClinicalTrials.gov ID
- NCT02049177
- Acronym / sponsor ID
- ARCAGE-NWE / 2/084/13
- Conditions
- Head and Neck Cancer
- Keywords
- Cancer, Epidemiology, Head and Neck, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jan 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.
Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important questions remain however, regarding the role of specific types of HPV, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol), and potential geographical differences in the effect of HPV.
Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is an international collaboartive case-control study conducted in 15 centres in 11 European countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a systematic analysis of HPV subtypes known or suspected to be involved in head and neck cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx, hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by exposure to other known or suspected carcinogens including tobacco, alcohol and medical history.
It is intended that this work will contribute to the development of evidence that may feed into treatment protocols for these cancers as well as evaluations of the feasibility for extending HPV vaccine programs.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer Cases | – | –Cases of Head and Neck Cancer identified in North West England in 2002/2003. Observational study - no intervention other than usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases that were previously identified for the HPV-AHEAD case-control study.
Key inclusion criteria (1 listed)
- Consent to follow-up and use of tissue samples
Key exclusion criteria (1 listed)
- No existing consent
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
HPV type
Time frame: From surgical/biopsy samples taken in 2002/2003, to be typed in 2014
3 secondary outcomes
Vital status
Time frame: 2014
Cancer Reccurrence
Time frame: 2002-2014
Secondary cancers
Time frame: 2002-2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Study WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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 Cancer, run by University of Aberdeen at 6 sites in United Kingdom.
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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV type (time frame: From surgical/biopsy samples taken in 2002/2003, to be typed in 2014). 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 8 Sep 2016.