A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

November 14, 2023 updated by: Centro di Riferimento Oncologico - Aviano
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

267

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

  • Name: Elisabetta Fratta, PhD
  • Phone Number: +390434659569
  • Email: efratta@cro.it

Study Contact Backup

Study Locations

  • Italy
      • Aviano, Italy
        • Recruiting
        • Centro di Riferimento Oncologico (CRO), IRCCS
        • Contact:
        • Principal Investigator:
          • Elisabetta Fratta, PhD
      • Belluno, Italy
      • Mestre, Italy
      • Pordenone, Italy
      • Treviso, Italy

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC

Description

Inclusion Criteria:

  • newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
  • managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
  • minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
  • neoplastic lesion contains ≥ 70% neoplastic cells

Exclusion Criteria:

Patients:

  • with distant metastases at diagnosis,
  • who have been managed with palliative intent;
  • with previous history of head and neck cancer are not eligible

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk of recurrence
Time Frame: 18 months
risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one
18 months

Collaborators and Investigators

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

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

  • Principal Investigator: Elisabetta Fratta, PhD, Centro di Riferimento Oncologico (CRO), IRCCS

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)

April 19, 2019

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO 2019.13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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