Human Papillomavirus and Oropharynx Carcinoma (Papillophar)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Oropharyngeal Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT00918710

AOM 08104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 362 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Squamous cell carcinoma of Oropharynx proven histologically
• All stages TNM
• informed consent
• No previous or simultaneous Head Neck cancer
• Age >18

Exclusion criteria

• Squamous cell carcinoma other than oropharynx
• 2nd synchronous SCC localization
• No consent
• age < 18

Trial design

362 participants in 1 patient group

1

Description:

Patients with oropharyngeal squamous cell carcinomas