NCT02049177

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

January 27, 2014

Last Update Submit

September 7, 2016

Conditions

Keywords

CancerEpidemiologyHead and NeckHPV

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Blackpool Victoria Infirmary

Blackpool, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

North Manchester General Hospital

Manchester, United Kingdom

Location

The Christie Hospital

Manchester, United Kingdom

Location

Royal Preston Hospital

Preston, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

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

Locations