Human Papillomavirus and Oropharynx Carcinoma
- Conditions
- Oropharyngeal Neoplasms
- Registration Number
- NCT00918710
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 362
- Squamous cell carcinoma of Oropharynx proven histologically
- All stages TNM
- informed consent
- No previous or simultaneous Head Neck cancer
- Age >18
- Squamous cell carcinoma other than oropharynx
- 2nd synchronous SCC localization
- No consent
- age < 18
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DFS at 2 years in HPV + and - tumors at 2 years
- Secondary Outcome Measures
Name Time Method HPV status At the inclusion Overall survival At 5 years
Trial Locations
- Locations (1)
Tenon Hospital, APHP
🇫🇷Paris, France
Tenon Hospital, APHP🇫🇷Paris, France