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NCT Number: NCT06133790

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.

Why the study stopped: Feasibility issue
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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Clairval

Marseille, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PCR - Immunohistochemistry - Immunolabelling

Genetic

Genetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors

Primary outcomes

  1. Molecular profile of oropharyngeal or oral cavity HPV positive and negative tumors

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: HPVNGS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Aug 20, 2026

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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