Human Papillomavirus and Oropharynx Carcinoma


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 Title of Study: “Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

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.

Arms, Groups and Cohorts

  • 1
    • Patients with oropharyngeal squamous cell carcinomas

Clinical Trial Outcome Measures

Primary Measures

  • DFS at 2 years in HPV + and – tumors
    • Time Frame: at 2 years

Secondary Measures

  • Overall survival
    • Time Frame: At 2 years
  • HPV status
    • Time Frame: At the inclusion
  • Overall survival
    • Time Frame: At 5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean LACAU, PhD, MD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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