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NCT00918710 Clinical Trial

Human Papillomavirus and Oropharynx Carcinoma

Oropharyngeal Neoplasms Clinical Trial

— Papillophar  

Official title:
Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00918710
Other study ID # AOM 08104
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 9, 2009
Last updated April 13, 2017
Start date May 2009
Est. completion date May 2017

Study information
Verified date March 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 362
Est. completion date May 2017
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Tenon Hospital, APHP Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary DFS at 2 years in HPV + and - tumors at 2 years
Secondary Overall survival At 2 years
Secondary HPV status At the inclusion
Secondary Overall survival At 5 years
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