NCT00918710

Human Papillomavirus and Oropharynx Carcinoma

Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 362 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS \> 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS. Secondary objective : virologic characteristics of HPV+ tumors.

Detailed description

The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.

Conditions

• Oropharyngeal Neoplasms

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-04-01
• Completion: 2017-05-01
• First posted: 2009-06-11
• Last updated: 2017-04-14

Locations

1 site across 1 country: France