Human Papillomavirus and Oropharynx Carcinoma (Papillophar)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00918710
First received: June 9, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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
Oropharyngeal Neoplasms

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • DFS at 2 years in HPV + and - tumors [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 324
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)
Groups/Cohorts
1
Patients with oropharyngeal squamous cell carcinomas

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with squamous cell carcinoma of oropharynx followed by the participating centers

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918710

Locations
France
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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00918710     History of Changes
Other Study ID Numbers: AOM 08104
Study First Received: June 9, 2009
Last Updated: November 14, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Squamous cell carcinoma of Oropharynx
Human papillomavirus.
Biological prognostic markers.

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014