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Clinical Trials/NCT04189003
NCT04189003
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country66 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oropharyngeal Cancer
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
66
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
November 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with HPV + oropharyngeal cancer

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Correlate identified HPV molecular signature with clinical-anatomo-pathological data.(18 months)
  • Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS(18 months)
  • Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR(18 months)
  • Number of Death of any cause, or eventual relapse(18 months)
  • Ratio of the number of copies of viral genes to the number of cells(18 months)
  • Precise description of HPV insertion localisation in human genome when HPV is integrated(18 months)

Study Sites (1)

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