Molecular Signatures of HPV+ ORL Cancers (OROPAP)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oropharyngeal Cancer, Human Papillomavirus-Related Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with HPV + oropharyngeal cancer Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORL Cancers, HPV+ tumor, molecular signature, human papillomavirus