Molecular Signatures of HPV+ ORL Cancers (OROPAP) (OROPAP)

Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers

The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Cancer; Human Papillomavirus-Related Carcinoma

Detailed Description

OROPAP is a monocentric exploratory study with retrospective inclusion of patients.

The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.

Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.

The HPV molecular signatures will be identified by the capture-HPV technique.

For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75015
      • Hopital Europeen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years

Description

Inclusion Criteria:

• Patients with HPV + oropharyngeal cancer

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix	Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR	Find in the peripheral blood of patients, the presence of circulating tumoral HPV DNA (ctDNA) by droplet based digital PCR and when it is possible compare chromosomal insertion patterns of HPV ct DNA as those found in tumors	18 months
Correlate identified HPV molecular signature with clinical-anatomo-pathological data.	Look for an association between the presence of specific HPV molecular signatures and clinical-anatomo-pathological data.	18 months
Number of Death of any cause, or eventual relapse	Look for an association between the presence of these molecular signatures and the survival of patients.	18 months
Ratio of the number of copies of viral genes to the number of cells	Measure the viral load of HPV in the tumor.	18 months
Precise description of HPV insertion localisation in human genome when HPV is integrated	Identify disrupted metabolic pathways in tumor cells.	18 months
Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS	Analyze of complete viral genomes and identify potential variants through sequencing data analysis	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Hélène PÉRÉ, PhD, AP-HP, Hôpital Européen Georges Pompidou

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: human papillomavirus; ORL Cancers; HPV+ tumor; molecular signature
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Oropharyngeal Neoplasms
• Other Study ID Numbers: APHP180166 (OTHER: AP-HP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared
• IPD Sharing Time Frame: one year after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No