A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Recruiting

• Conditions: Oropharyngeal Squamous Cell Carcinoma

• Registration Number: NCT06138483
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-19
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk of recurrence	18 months	risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one

Trial Locations

Locations (5)

Centro di Riferimento Oncologico (CRO), IRCCS; 🇮🇹 Aviano, Italy

Ospedale San Martino di Belluno - ULSS 1 Dolomiti; 🇮🇹 Belluno, Italy

Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima; 🇮🇹 Mestre, Italy

Ospedale Santa Maria degli Angeli - ASFO; 🇮🇹 Pordenone, Italy

Ospedale di Treviso - ULSS 2 Marca Trevigiana; 🇮🇹 Treviso, Italy