Exploring biomarkers in patients with HPV-related head and neck cancer
Official title: Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Run by Regina Elena Cancer Institute · NCT06821243 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | July 24, 2024 |
| Main results expected | July 24, 2026 |
| Study ends | July 24, 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT06821243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years with squamous cell carcinoma of the oropharynx who are candidates for surgical intervention.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on HPV-related cancers, this specific approach to biomarker discovery in oropharyngeal cancer is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immune biomarker testing in cisplatin-ineligible head and neck squamous cell cancer patients treated with chemoradiation and docetaxel
This project will test whether immune markers from tumor tissue, blood, saliva and stool can help predict outcomes and show increased tumor immune activity in people with oropharynx, hypopharynx, larynx or oral cavity squamous cell cancer who can't take cisplatin and are receiving chemoradiation with docetaxel.
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Using blood HPV DNA to guide treatment in HPV-positive throat cancer
This trial tests whether a blood HPV DNA test can let doctors safely reduce post-surgery radiation for people with HPV-positive throat cancer.
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Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer
This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.
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New blood test to reduce radiation in HPV-related throat cancer treatment
This study is testing a new blood test to see if it can help identify patients with HPV-related throat cancer who might not need radiation after surgery, aiming to reduce side effects while keeping survival rates high.
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Monitoring HPV DNA in patients with throat cancer
This study is testing if checking for HPV DNA in the blood of throat cancer patients can help doctors spot any remaining cancer or recurrences after treatment.
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New method to monitor HPV16-related throat cancer recurrence
This study is testing if measuring HPV16 DNA in the blood can help doctors better monitor throat cancer patients for signs of recurrence, so they can provide more personalized follow-up care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.