Investigation of the Role of Human Papilloma Virus (HPV) in the Prognosis of Head and Neck Cancer
ARCAGE-NWE
Alcohol Related Cancers and Genetic Susceptibility in Europe Follow-up - North-West England
1 other identifier
observational
141
1 country
6
Brief 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), 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2013
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedSeptember 8, 2016
September 1, 2016
5 months
January 27, 2014
September 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HPV type
From surgical/biopsy samples taken in 2002/2003, to be typed in 2014
Secondary Outcomes (3)
Vital status
2014
Cancer Reccurrence
2002-2014
Secondary cancers
2002-2014
Study Arms (1)
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.
Eligibility Criteria
Cases that were previously identified for the HPV-AHEAD case-control study.
You may qualify if:
- Consent to follow-up and use of tissue samples
You may not qualify if:
- No existing consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Royal Blackburn Hospital
Blackburn, United Kingdom
Blackpool Victoria Infirmary
Blackpool, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2014
First Posted
January 30, 2014
Study Start
November 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
September 8, 2016
Record last verified: 2016-09