Molecular Signatures of HPV+ ORL Cancers (OROPAP)

Overview

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

Full Title of Study: “Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 30, 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 18 months
    • Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with HPV + oropharyngeal cancer Exclusion Criteria:

  • NA

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hélène PÉRÉ, PhD, Study Director, AP-HP, Hôpital Européen Georges Pompidou

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