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Trial Title:
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
NCT ID:
NCT06138483
Condition:
Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Oropharyngeal Squamous Cell Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed
stage III-IVa OPSCC
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO), IRCCS
Address:
City:
Aviano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisabetta Fratta, MD
Email:
efratta@cro.it
Investigator:
Last name:
Elisabetta Fratta, PhD
Email:
Principal Investigator
Facility:
Name:
Ospedale San Martino di Belluno - ULSS 1 Dolomiti
Address:
City:
Belluno
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Furlan, MD
Email:
carlo.furlan@aulss1.veneto.it
Facility:
Name:
Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima
Address:
City:
Mestre
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Doriano Politi, MD
Email:
doriano.politi@aulss3.veneto.it
Facility:
Name:
Ospedale Santa Maria degli Angeli - ASFO
Address:
City:
Pordenone
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vittorio Giacomarra
Email:
vittorio.giacomarra@asfo.sanita.fvg.it
Facility:
Name:
Ospedale di Treviso - ULSS 2 Marca Trevigiana
Address:
City:
Treviso
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Boscolo-Rizzo, MD
Email:
segorltv@aulss2.veneto.it
Start date:
April 19, 2019
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06138483
