Human Papillomavirus and Oropharynx Carcinoma (Papillophar)
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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. |
- DFS at 2 years in HPV + and - tumors [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
- 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 |
Patients with squamous cell carcinoma of oropharynx followed by the participating centers
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| France | |
| Tenon Hospital, APHP | |
| Paris, France, 75020 | |
| 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 16, 2012 |
| 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 May 22, 2013