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Papillophar: Human Papillomavirus and Oropharynx Carcinoma

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT00918710
Collaborator
(none)
362
Enrollment
1
Location
96
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    362 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
    Actual Study Start Date :
    May 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2014
    Anticipated Study Completion Date :
    May 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Patients with oropharyngeal squamous cell carcinomas

    Outcome Measures

    Primary Outcome Measures

    1. DFS at 2 years in HPV + and - tumors [at 2 years]

    Secondary Outcome Measures

    1. Overall survival [At 2 years]

    2. HPV status [At the inclusion]

    3. Overall survival [At 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tenon Hospital, APHP Paris France 75020

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Jean LACAU, PhD, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT00918710
    Other Study ID Numbers:
    • AOM 08104
    First Posted:
    Jun 11, 2009
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Squamous cell carcinoma of Oropharynx
    Human papillomavirus.
    Biological prognostic markers.
    Additional relevant MeSH terms:
    Carcinoma
    Oropharyngeal Neoplasms

    Study Results

    No Results Posted as of Apr 14, 2017