Observing viral biomarkers and microRNAs in oropharyngeal tumors and occult cancers related to HPV
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
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 |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05918510 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using biomarkers for HPV-related cancers, but this specific approach is novel and untested.
Eligibility criteria
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 this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Raul Pellini, Doctor
- Email: raul.pellini@ifo.gov.it
- Phone: 06-52664484
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.