Clinical Trial: Human Papillomavirus and Oropharynx Carcinoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: DFS at 2 years in HPV + and - tumors [ Time Frame: at 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival [ Time Frame: At 2 years ]
- HPV status [ Time Frame: At the inclusion ]
- Overall survival [ Time Frame: At 5 years ]
Original Secondary Outcome:
- Overall survival [ Time Frame: At 2 years ]
- HPV status [ Time Frame: At the inclusion ]
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: June 9, 2009
Date Started: May 2009
Date Completion: May 2017
Last Updated: April 13, 2017
Last Verified: March 2017
