A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
Study Details
Study Description
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
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Study Design
Outcome Measures
Primary Outcome Measures
- risk of recurrence [18 months]
risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one
Eligibility Criteria
Criteria
Inclusion Criteria:
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newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
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managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
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minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
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neoplastic lesion contains ≥ 70% neoplastic cells
Exclusion Criteria:
Patients:
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with distant metastases at diagnosis,
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who have been managed with palliative intent;
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with previous history of head and neck cancer are not eligible
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro di Riferimento Oncologico (CRO), IRCCS | Aviano | Italy | ||
| 2 | Ospedale San Martino di Belluno - ULSS 1 Dolomiti | Belluno | Italy | ||
| 3 | Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima | Mestre | Italy | ||
| 4 | Ospedale Santa Maria degli Angeli - ASFO | Pordenone | Italy | ||
| 5 | Ospedale di Treviso - ULSS 2 Marca Trevigiana | Treviso | Italy |
Sponsors and Collaborators
- Centro di Riferimento Oncologico - Aviano
Investigators
- Principal Investigator: Elisabetta Fratta, PhD, Centro di Riferimento Oncologico (CRO), IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRO 2019.13