Molecular Signatures of HPV+ ORL Cancers (OROPAP)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04189003

Acronym

OROPAP

Enrollment

Registered

2019-12-06

Start date

2019-06-01

Completion date

2020-11-30

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus-Related Carcinoma, Oropharyngeal Cancer

Keywords

ORL Cancers, HPV+ tumor, molecular signature, human papillomavirus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with HPV + oropharyngeal cancer

Exclusion criteria

* NA

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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
Precise description of HPV insertion localisation in human genome when HPV is integrated	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	18 months	Analyze of complete viral genomes and identify potential variants through sequencing data analysis
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.

Countries

France

Outcome results