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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133790
Collaborator
(none)
60
5.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Assessment of Genomic Alterations and Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Jérôme PARIS, MD, Hôpital privé de Clairval

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT06133790
Other Study ID Numbers:
  • 2023-A00936-39
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023