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RECRUITING
NCT05918510

Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Sponsor: Regina Elena Cancer Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

142

Start Date

2022-04-04

Completion Date

2029-04-04

Last Updated

2023-10-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

The prospective observational study involves the collection of tissue, blood and saliva samples from OPSCC and occult T patients for detection of HPV-DNA/RNA, miRNA and mutation profile from DNA with centralized analysis of samples at IRCCS Regina Elena National Cancer Institute.

Locations (1)

"Regina Elena" National Cancer Institute

Rome, Italy