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

NCT06706973 | Recruiting

• 1 other identifier: IEO 1972
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Keywords

PROFILING AND TARGETING EPIGENETIC MARKS; HEAD AND NECK CANCER

Outcome Measures

Primary Outcomes (1)

• PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER

  define and fully characterize histone Post-Translational Modifications (hPTMs) and differentially expressed chromatin modifiers in HPV+ vs HPV- HNC through cutting-edge methodologies

  2 years

Study Arms (1)

patient with head and neck SCC

Anatomic location: oral cavity, larynx, oropharynx

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

patients that will undergo surgical tumor removal at the Otolaryngology - head and neck surgery unit of the IEO. Samples will be collected from at least 60 HNC primary tumors

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead
• AIRC (Italian Association for Cancer Research): collaborator

Study Sites (1)

European Institute of oncology

Milan, MI, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, tissue.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Susanna Chiocca

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Chiocca, Doctor

CONTACT

00390257488835; susanna.chiocca@ieo.it

francesca lombardi, dr

CONTACT

0039-02-57489425; francesca.lombardi@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: March 6, 2024
• Primary Completion (Estimated): April 4, 2030
• Study Completion (Estimated): April 4, 2030
• Last Updated: November 27, 2024

Record last verified: 2024-10

Locations

IT (1)