A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-19

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Oropharyngeal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No