Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment142 (estimated)
SponsorRegina Elena Cancer Institute
Academic / other
Locations1 site (Rome)
StatusRecruiting
StartedApril 4, 2022
Main results expectedApril 4, 2024
Study endsApril 4, 2029
Registry record updatedOctober 10, 2023
Trial IDNCT05918510 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.