Investigation of the Role of Human Papilloma Virus (HPV) in the Prognosis of Head and Neck Cancer (ARCAGE-NWE)

September 7, 2016 updated by: University of Aberdeen

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Blackburn, United Kingdom
        • Royal Blackburn Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Infirmary
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Manchester, United Kingdom
        • The Christie Hospital
      • Manchester, United Kingdom
        • North Manchester General Hospital
      • Preston, United Kingdom
        • Royal Preston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases that were previously identified for the HPV-AHEAD case-control study.

Description

Inclusion Criteria:

  • Consent to follow-up and use of tissue samples

Exclusion Criteria:

  • No existing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HPV type
Time Frame: From surgical/biopsy samples taken in 2002/2003, to be typed in 2014
From surgical/biopsy samples taken in 2002/2003, to be typed in 2014

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital status
Time Frame: 2014
2014
Cancer Reccurrence
Time Frame: 2002-2014
2002-2014
Secondary cancers
Time Frame: 2002-2014
2002-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

International Agency for Research on Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/084/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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