Actively Recruiting
Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Led by Regina Elena Cancer Institute · Updated on 2026-06-05
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
U
University of Campania Luigi Vanvitelli
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective pilot observational study focused on patients with squamous cell carcinoma of the oropharynx (OPSCC) linked to human papillomavirus (HPV). The study aims to discover predictive biomarkers that can guide clinical care by analyzing biological and radiological data. Important goals include understanding the levels of circulating HPV-DNA and immune system responses in these patients. Participants will provide tissue samples and blood to detect HPV-DNA/RNA and to perform immune cell analysis, study extracellular vesicles, and measure cytokines and chemokines involved in immune responses. Radiological images will be collected during diagnosis and treatment for research purposes but will not influence patient care decisions. No genomic or protein molecular analyses will be performed. Throughout the study, researchers will monitor HPV-DNA levels circulating in blood over 24 months and study immune cells and extracellular vesicles during this time. The study will follow patients from diagnosis through their care pathway, ensuring detailed data collection without affecting treatment. This allows for a comprehensive understanding of HPV-associated OPSCC and supports future improvements in managing this cancer.
CONDITIONS
Brief Title
Patients With Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Squamous cell carcinoma of the oropharynx (OPSCC) patients who are candidates for surgery
- Age greater than 18 years
- ECOG performance status of 2 or less
- Signed informed consent to participate and for data processing
You will not qualify if you...
- Presence of distant metastases at diagnosis
- Previous head and neck cancer
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to diagnosis and care pathway start
Participants undergo collection of tissue samples, blood draws, and radiological imaging as part of diagnosis and assessment of HPV-associated oropharynx cancer.
1 to 2 visits depending on diagnostic procedures
Duration - Up to 24 months
Participants are observed with periodic blood tests and immuno-phenotypic analyses over time to study HPV-DNA levels and immune response during their care pathway.
Periodic visits for blood collection and imaging during routine care
Trial Site Locations
Total: 1 location
1
IRCCS National Cancer Institute "Regina Elena"
Rome, Rome, Italy, 00144
Actively Recruiting
Research Team
A
Antonello Vidiri, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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