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NCT06138483 Clinical Trial

A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06138483
Other study ID # CRO 2019.13
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 19, 2019
Est. completion date June 30, 2025

Study information
Verified date November 2023
Source Centro di Riferimento Oncologico - Aviano
Contact Elisabetta Fratta, PhD
Phone +390434659569
Email efratta@cro.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 267
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy 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

Sponsors (1)
Lead Sponsor Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary risk of recurrence risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one 18 months
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