Human Papillomavirus and Oropharynx Carcinoma | NCT00918710

Studies
Human Papillomavirus and Oropharynx Carcinoma

NCT00918710

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Apr 14, 2017Actual

Enrollment

362Actual

Phase

Not provided

Conditions

Oropharyngeal Neoplasms

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009Actual

Primary Completion Date

Apr 2014Actual

Completion Date

May 2017Estimated

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2017

Last Update Posted Date

Apr 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

362Actual

Label	Type	Description	Intervention Names
1		Patients with oropharyngeal squamous cell carcinomas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS at 2 years in HPV + and - tumors		at 2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		At 2 years
HPV status		At the inclusion
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean LACAU, PhD, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tenon Hospital, APHP		Paris		75020	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35199231	Derived	Pretet JL, Dalstein V, Touze A, Beby-Defaux A, Soussan P, Jacquin E, Birembaut P, Clavel C, Mougin C, Rousseau A, Lacau Saint Guily J; Papillophar Study Group. High levels of HPV16-L1 antibody but not HPV16 DNA load or integration predict oropharyngeal patient outcome: The Papillophar study. Clin Exp Med. 2023 Feb;23(1):87-96. doi: 10.1007/s10238-022-00796-2. Epub 2022 Feb 23.

ID	Term
D009959	Oropharyngeal Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site