Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer (AIRC-Chiocca)

November 26, 2024 updated by: European Institute of Oncology
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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20141
        • Recruiting
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patient with head and neck SCC
Anatomic location: oral cavity, larynx, oropharynx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

AIRC (Italian Association for Cancer Research)

Investigators

  • Principal Investigator: Susanna Chiocca, Istituto Europeo di Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

April 4, 2030

Study Completion (Estimated)

April 4, 2030

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1972

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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