Molecular Signatures of HPV+ ORL Cancers (OROPAP)

Oropharyngeal Cancer Clinical Trial

— OROPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189003
• Other study ID #: APHP180166
• Secondary ID: APHP180166
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with HPV + oropharyngeal cancer

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Human Papillomavirus-Related Carcinoma
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Precise description of HPV insertion localisation in human genome when HPV is integrated	Identify disrupted metabolic pathways in tumor cells.	18 months
Secondary	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