Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00918710
Status:
UNKNOWN
Last Update Posted:
2017-04-14
First Post:
2009-06-09
Brief Title:
Human Papillomavirus and Oropharynx Carcinoma
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of the Human Papillomavirus HPV Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Papillophar
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
Secondary objective virologic characteristics of HPV tumors
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None