Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers (HPVNGS)

Assessment of Genomic Alterations and Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers

Squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination.

Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies and others to radiotherapy. However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Genetic: PCR - Immunohistochemistry - Immunolabelling

Detailed Description

Head and neck cancers are the sixth most common cancer common worldwide causing more than 380,000 deaths each year. More than 90% of these cancers are carcinomas epidermoids arising from the mucosal surfaces of the cavity oral cavity, oropharynx and larynx.

Squamous cell cancers of the head and neck are classically correlated with risk factors linked to excessive consumption of alcohol and tobacco and have a rather poor prognosis (mainly HPV (Human Papilloma Virus) negative patients).

However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination. Evolution of oral sexual practices seems to be one of the explanations for the progression of these cases of oropharyngeal squamous cell carcinoma and oral cavity HPV positive.

Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies (CCND1, TYMS) and others to radiotherapy (RBBP4). However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment. This is the context of this research project.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jérôme PARIS, MD; Phone Number: + 33 4 91 17 17 70; Email: j.paris@me.com

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Hopital Prive Clairval
    • Contact: Jérôme PARIS, MD; Phone Number: + 33 4 91 17 17 70; Email: j.paris@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with Head and Neck cancer and HPV diagnosis

Description

Inclusion Criteria:

• Patient with oropharyngeal squamous cell carcinoma or the oral cavity histologically proven.
• Primary tumor for which a biopsy or excision is required available and sufficient to carry out molecular analysis

Exclusion Criteria:

- Patient with Head and Neck cancer other than oropharyngeal or oral cavity squamous cells carcinomas

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HPV + Group; Patients with positive HPV diagnosis	Genetic: PCR - Immunohistochemistry - Immunolabelling; Genetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors
HPV - Group; Patients with negative HPV diagnosis	Genetic: PCR - Immunohistochemistry - Immunolabelling; Genetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular profile of oropharyngeal or oral cavity HPV positive and negative tumors	Molecular profile of tumors will be established with analysis of 87 "Hotspot" genes, full length analysis of 48 genes, copy number analysis of 43 genes and gene fusion (inter and intra genic) of 51 genes.	1 day

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Jérôme PARIS, MD, Hôpital privé de Clairval

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2023-A00936-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No