Observing viral biomarkers and microRNAs in oropharyngeal tumors and occult cancers related to HPV
Official title: Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
Run by Regina Elena Cancer Institute · NCT05918510 · Data updated 2026-11-12
This study is testing if certain viral markers and microRNAs in oropharyngeal tumors can help doctors better diagnose and monitor HPV-related cancers and find new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | April 4, 2022 |
| Main results expected | April 4, 2024 |
| Study ends | April 4, 2029 |
| Registry record updated | October 10, 2023 |
| Trial ID | NCT05918510 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with squamous cell carcinomas of the oropharynx or occult neoplasms with lymph node metastases who have undergone specific treatments.
✕Probably not a fit
Patients with distant metastases at diagnosis or those with a history of previous head and neck cancers 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 aims to investigate the presence and expression of HPV-DNA, specific microRNAs, and mutational profiles in patients with squamous cell carcinoma of the oropharynx and occult tumors. By analyzing tissue and biological fluids, the study seeks to determine the prognostic and diagnostic value of these biomarkers. Additionally, it aims to enhance the sensitivity and specificity of existing radiological methods like PET-CT and MRI for monitoring disease progression. The collected samples will also be used to create organoids and Patient Derived Xenografts (PDX) to explore potential new molecular drugs for overcoming resistance to treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for patients with HPV-related oropharyngeal cancers.
How similar studies have gone: Other studies have shown promise in using biomarkers for HPV-related cancers, but this specific approach is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT * Age \> 18 years * ECOG performance status \<\_ 2 * Ability to follow study procedures and complete questionnaires * Signature of informed consent Exclusion Criteria: * Presence of distant metastases at the time of diagnosis * Previous cancer of the head and neck district * Second tumor in therapy or follow-up for less than 5 years
Where it's running
-
"Regina Elena" National Cancer Institute
Rome, Italy Recruiting
Study contacts
- Study coordinator: Raul Pellini, Doctor
- Email: raul.pellini@ifo.gov.it
- Phone: 06-52664484
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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.