NCT06821243

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

Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study 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. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.

Conditions

• Squamous Cell Carcinoma of Oropharynx

Timeline

• Start date: 2024-07-24
• Primary completion: 2026-07-24
• Completion: 2026-07-24
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: Italy