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A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06138483
Enrollment
267
Registered
2023-11-18
Start date
2019-04-19
Completion date
2025-06-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Squamous Cell Carcinoma

Keywords

Oropharyngeal Squamous Cell Carcinoma

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

Interventions

None listed

Sponsors

Centro di Riferimento Oncologico - Aviano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
risk of recurrence18 monthsrisk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one

Countries

Italy

Contacts

Primary ContactElisabetta Fratta, PhD
efratta@cro.it+390434659569
Backup ContactGiuseppe Fanetti, MD
giuseppe.fanetti@cro.it+390434659525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026