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.
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
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
Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases Cytologically positive laterocervical squamous cell carcinoma treated with TORS or RT or RT/CT
Cohort
Prospective
Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
Diagnostic testThe 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.
Accouracy
Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.
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Regina Elena Cancer Institute
Lead sponsor
Istituto Clinico Humanitas
Collaborator
Istituto Europeo di Oncologia
Collaborator
Azienda Policlinico Umberto I
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
University of Firenze and Siena, Napoli, Italy
Collaborator
Weizmann Institute of Science
Collaborator
