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

NCT06133790 | Recruiting

• 1 other identifier: 2023-A00936-39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HPV + Group

Patients with positive HPV diagnosis

Genetic: PCR - Immunohistochemistry - Immunolabelling

HPV - Group

Patients with negative HPV diagnosis

Genetic: PCR - Immunohistochemistry - Immunolabelling

Interventions

PCR - Immunohistochemistry - Immunolabelling GENETIC

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

HPV + Group; HPV - Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Head and Neck cancer and HPV diagnosis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA is extracted from biopsies

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jérôme PARIS, MD

  Hôpital privé de Clairval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme PARIS, MD

CONTACT

+ 33 4 91 17 17 70; j.paris@me.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 15, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)