Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer

Recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT06706973
• Lead Sponsor: European Institute of Oncology

Brief Summary

Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and feasible option to build upon. Our overarching hypothesis is that unique histone marks distinguish HPV+ and HPV- HNC and that specific histone modifiers are novel mediators of HNC tumorigenesis in an HPV specific manner

Detailed Description

Head and neck cancer (HNC) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. HNC risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (OPC), human papillomavirus (HPV) infection

Study Timeline

• Study Start: 2024-03-06
• Status Verified: 2024-10
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2030-04-04
• Study Completion: 2030-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age: Adults aged ≥ 18 years diagnosed with HNC

• Sex: Both male and female
• Human papilloma virus (HPV) test: Both positive and negative.
• Tumor: primary tumors, treatment naïve, squamous cell carcinoma
• Cancer stage: I-IV
• Anatomic location: oral cavity, larynx, oropharynx
• Tumor fragments not required for diagnostics

Exclusion Criteria

• Previous radiotherapy, chemotherapy or immunotherapy for HNC
• Unable to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER	2 years	define and fully characterize histone Post-Translational Modifications (hPTMs) and differentially expressed chromatin modifiers in HPV+ vs HPV- HNC through cutting-edge methodologies

Trial Locations

Locations (1)

European Institute of oncology; 🇮🇹 Milan, MI, Italy