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Search / Trial NCT06138483

A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Launched by CENTRO DI RIFERIMENTO ONCOLOGICO - AVIANO · Nov 14, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Oropharyngeal Squamous Cell Carcinoma

ClinConnect Summary

This clinical trial is studying a new way to identify oropharyngeal squamous cell carcinoma (OPSCC) patients who are at high risk for their cancer coming back early. The researchers are looking at specific genetic changes and markers that might help predict which patients will have a relapse, especially focusing on those with HPV-positive and HPV-negative cancer. By understanding these changes, the goal is to improve personalized treatment for patients and help doctors make better decisions about their care.

To be eligible for this trial, participants must be newly diagnosed with advanced stage OPSCC, meaning their cancer is at stage III or IVa, and have not received any treatment yet. They will also need to have a certain amount of cancer cells in their tissue sample. Participants should expect regular follow-ups and assessments during the study, which will last for at least two years after treatment. Importantly, people who have cancer that has spread to other parts of the body or those who have had previous head and neck cancers cannot join the trial. This research is currently recruiting participants and aims to help improve future treatment options for OPSCC patients.

Gender

ALL

Eligibility criteria

  • 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

About Centro Di Riferimento Oncologico Aviano

Centro di Riferimento Oncologico - Aviano is a leading cancer research and treatment center in Italy, dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. As a prominent institution in the field, it specializes in the development of new therapies and diagnostic approaches, leveraging a multidisciplinary team of experts to enhance treatment outcomes. The center actively collaborates with national and international research networks, fostering a commitment to improving cancer care and contributing to the global understanding of oncology through rigorous scientific inquiry.

Locations

Aviano, , Italy

Belluno, , Italy

Mestre, , Italy

Pordenone, , Italy

Treviso, , Italy

Patients applied

0 patients applied

Trial Officials

Elisabetta Fratta, PhD

Principal Investigator

Centro di Riferimento Oncologico (CRO), IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported