Human Papillomavirus and Oropharynx Carcinoma
Papillophar
Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
1 other identifier
observational
362
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedApril 14, 2017
March 1, 2017
4.9 years
June 9, 2009
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DFS at 2 years in HPV + and - tumors
at 2 years
Secondary Outcomes (3)
Overall survival
At 2 years
HPV status
At the inclusion
Overall survival
At 5 years
Study Arms (1)
1
Patients with oropharyngeal squamous cell carcinomas
Eligibility Criteria
Patients with squamous cell carcinoma of oropharynx followed by the participating centers
You may qualify if:
- Squamous cell carcinoma of Oropharynx proven histologically
- All stages TNM
- informed consent
- No previous or simultaneous Head Neck cancer
- Age \>18
You may not qualify if:
- Squamous cell carcinoma other than oropharynx
- nd synchronous SCC localization
- No consent
- age \< 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tenon Hospital, APHP
Paris, 75020, France
Related Publications (1)
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.
PMID: 35199231DERIVED
Biospecimen
Pieces of Oropharyngeal squamous cell carcinomas biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean LACAU, PhD, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 11, 2009
Study Start
May 1, 2009
Primary Completion
April 1, 2014
Study Completion
May 1, 2017
Last Updated
April 14, 2017
Record last verified: 2017-03