UnknownNot Applicable

A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Italy267 participantsStarted 2019-04-19

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

risk of recurrence

Timeframe: 18 months

Trial details

NCT IDNCT06138483

SponsorCentro di Riferimento Oncologico - Aviano

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

Contact for this trial

Elisabetta Fratta, PhD

+390434659569 efratta@cro.it