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

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.

NCT Number	NCT05918510
Lead Sponsor	Regina Elena Cancer Institute Collaborators: Istituto Clinico Humanitas, Istituto Europeo di Oncologia, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Firenze and Siena, Napoli, Italy, Weizmann Institute of Science
Conditions	Squamous Cell Carcinoma of the Oropharynx, Carcinomas of Unknown Primary Site, High-risk Human Papillomavirus Infection, Liquid Biopsy, Lymph Node Metastasis, Occult Tumor of the Head and Neck Area
Enrollment	142 participants
Start Date	2022-04-04
Primary Completion	2024-04-04 (estimated)
Study Completion	2029-04-04 (estimated)
Updated on ClinicalTrials.gov	2023-10-10