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

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Intervention / Treatment
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* Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>High miR value | Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx<br>* 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.<br>|
| Group 2<br>Control group | Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oropharyngeal Tumor, Occult Cancer, HPV Infection, head-neck area