NCT05918510 Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
| NCT ID | NCT05918510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Squamous Cell Carcinoma of the Oropharynx |
| Study Type | OBSERVATIONAL |
| Enrollment | 142 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2024-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 142 participants in total. It began in 2022-04-04 with a primary completion date of 2024-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05918510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma of the Oropharynx. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05918510 currently recruiting?
Yes, NCT05918510 is actively recruiting participants. Contact the research team at raul.pellini@ifo.gov.it for enrollment information.
Where is the NCT05918510 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05918510 clinical trial?
NCT05918510 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 142 participants.