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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aviano, , Italy
Belluno, , Italy
Mestre, , Italy
Pordenone, , Italy
Treviso, , Italy
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