Exploring biomarkers in patients with HPV-related head and neck cancer
Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
This study looks at patients with HPV-related throat cancer to see how their body responds to treatment by checking their blood and tissue samples for HPV and immune markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT06821243 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with squamous cell carcinoma of the oropharynx associated with human papillomavirus (HPV). It involves the collection of tissue and blood samples to detect HPV-DNA/RNA and analyze T cells, extracellular vesicles, and immune response markers. The study aims to observe the levels of circulating HPV-DNA in patients throughout their treatment journey, without altering their clinical care. Radiological images will also be collected for exploratory purposes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with squamous cell carcinoma of the oropharynx who are candidates for surgical intervention.
Not a fit: Patients with distant metastases at diagnosis or those with a history of previous head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of HPV-associated oropharyngeal cancers.
How similar studies have performed: While there have been studies on HPV-related cancers, this specific approach to biomarker discovery in oropharyngeal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Presence of distant metastases at the time of diagnosis * Previous head and neck cancer
Where this trial is running
Rome, Rome
- IRCCS National Cancer Institute "Regina Elena" — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Antonello Vidiri, Medical Doctor
- Email: antonello.vidiri@ifo.it
- Phone: +39 0652665071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.