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| Name | Class |
|---|---|
| Istituto Clinico Humanitas | OTHER |
| Istituto Europeo di Oncologia | OTHER |
| Azienda Policlinico Umberto I | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | High miR value |
| |
| Group 2 | Control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx | Diagnostic Test | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raul Pellini, Doctor | Contact | 06-52664484 | raul.pellini@ifo.gov.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |
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| OTHER |
| University of Firenze and Siena, Napoli, Italy | OTHER |
| Weizmann Institute of Science | OTHER |
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|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008207 | Lymphatic Metastasis |
| D009959 | Oropharyngeal Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
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