Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers

Head and Neck Cancer Clinical Trial

— HPVNGS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133790
• Other study ID #: 2023-A00936-39
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Jérôme PARIS, MD
• Phone: + 33 4 91 17 17 70
• Email: j.paris[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Genetic:
• PCR - Immunohistochemistry - Immunolabelling
Genetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors

Locations

Country	Name	City	State
France	Hôpital Privé Clairval	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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