Patients with Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention

NCT06821243 | Recruiting

• 1 other identifier: RS193/IRE/24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response

Conditions

Squamous Cell Carcinoma of Oropharynx

Keywords

carcinoma of the oropharynx; squamous cell carcinoma of the oropharynx; head and neck

Outcome Measures

Primary Outcomes (1)

• Observe the kinetics of HPV-DNA levels circulating in the blood

  ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.

  24 months

Secondary Outcomes (2)

• Immuno-phenotyping at the tissue and blood level

  24 months

• Isolation of extracellular vesicles

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by oropharynx squamous cell carcinoma (OPSCC) in head and neck district

You may qualify if:

• Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
• Age \> 18 years
• ECOG performance status \<\_ 2
• Signature of informed consent (to participate in the study and data processing)

You may not qualify if:

• Presence of distant metastases at the time of diagnosis
• Previous head and neck cancer

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Università della Campania Luigi Vanvitelli: collaborator
• Università di Napoli Federico II: collaborator
• I.R.C.C.S. Fondazione Santa Lucia, Italy: collaborator

Study Sites (1)

IRCCS National Cancer Institute "Regina Elena"

Rome, Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

samples of tissue and liquid biopsy

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Antonello Vidiri, Medical Doctor

CONTACT

+39 0652665071; antonello.vidiri@ifo.it

Study Design

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

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)