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Human Papillomavirus and Oropharynx Carcinoma (Papillophar)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918710
First Posted: June 11, 2009
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: At 2 years ]
  • HPV status [ Time Frame: At the inclusion ]
  • Overall survival [ Time Frame: At 5 years ]

Biospecimen Retention:   Samples With DNA
Pieces of Oropharyngeal squamous cell carcinomas biopsies

Enrollment: 362
Actual Study Start Date: May 2009
Estimated Study Completion Date: May 2017
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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00918710     History of Changes
Other Study ID Numbers: AOM 08104
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: April 14, 2017
Last Verified: March 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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases