Molecular Signatures of HPV+ ORL Cancers (OROPAP)

Completed

• Conditions: Human Papillomavirus-Related Carcinoma; Oropharyngeal Cancer

• Registration Number: NCT04189003
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients with HPV + oropharyngeal cancer

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	18 months	Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, Ile-de-France, France