Human Papillomavirus and Oropharynx Carcinoma (Papillophar)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.|
- DFS at 2 years in HPV + and - tumors [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
- HPV status [ Time Frame: At the inclusion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Pieces of Oropharyngeal squamous cell carcinomas biopsies
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Patients with oropharyngeal squamous cell carcinomas
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 2 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918710
|Tenon Hospital, APHP|
|Paris, France, 75020|
|Principal Investigator:||Jean LACAU, PhD, MD||Assistance Publique - Hôpitaux de Paris|