A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Last updated: November 14, 2023
Sponsor: Centro di Riferimento Oncologico - Aviano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Squamous Cell Carcinoma

Head And Neck Cancer

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT06138483
CRO 2019.13
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 adjuvantradiotherapy ± chemotherapy or definitive chemo-radiotherapy)
  • minimum follow up of 2 years or who had disease recurrence within 2 years after theend of treatment.
  • neoplastic lesion contains ≥ 70% neoplastic cells

Exclusion

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

Total Participants: 267
Study Start date:
April 19, 2019
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Centro di Riferimento Oncologico (CRO), IRCCS

    Aviano,
    Italy

    Active - Recruiting

  • Ospedale San Martino di Belluno - ULSS 1 Dolomiti

    Belluno,
    Italy

    Active - Recruiting

  • Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima

    Mestre,
    Italy

    Active - Recruiting

  • Ospedale Santa Maria degli Angeli - ASFO

    Pordenone,
    Italy

    Active - Recruiting

  • Ospedale di Treviso - ULSS 2 Marca Trevigiana

    Treviso,
    Italy

    Active - Recruiting

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