A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

NCT06138483 | Unknown

• 1 other identifier: CRO 2019.13
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 5

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

Conditions

Oropharyngeal Squamous Cell Carcinoma

Keywords

Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• risk of recurrence

  risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC

You may qualify if:

• 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

You may not qualify if:

• Patients:
• with distant metastases at diagnosis,
• who have been managed with palliative intent;
• with previous history of head and neck cancer are not eligible

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (5)

Centro di Riferimento Oncologico (CRO), IRCCS

Aviano, Italy

RECRUITING

Ospedale San Martino di Belluno - ULSS 1 Dolomiti

Belluno, Italy

RECRUITING

Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima

Mestre, Italy

RECRUITING

Ospedale Santa Maria degli Angeli - ASFO

Pordenone, Italy

RECRUITING

Ospedale di Treviso - ULSS 2 Marca Trevigiana

Treviso, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Elisabetta Fratta, PhD

  Centro di Riferimento Oncologico (CRO), IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Fratta, PhD

CONTACT

+390434659569; efratta@cro.it

Giuseppe Fanetti, MD

CONTACT

+390434659525; giuseppe.fanetti@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: April 19, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)