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Completed

NCT Number: NCT04189003

Molecular Signatures of HPV+ ORL Cancers (OROPAP)

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

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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Human Papillomavirus-Related Carcinoma Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with HPV + oropharyngeal cancer

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Precise description of HPV insertion localisation in human genome when HPV is integrated

    Time frame: 18 months

    Identify disrupted metabolic pathways in tumor cells.

  6. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OROPAP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2019
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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