Carcinomas of Unknown Primary Site, High-risk Human Papillomavirus Infection, Liquid Biopsy, Lymph Node Metastasis, Occult Tumor of the Head and Neck Area, Squamous Cell Carcinoma of the Oropharynx
Conditions
Keywords
Oropharyngeal Tumor, Occult Cancer, HPV Infection, head-neck area
Brief 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.
Interventions
DIAGNOSTIC_TESTStudy 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.
Sponsors
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
Regina Elena Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accouracy | Baseline | 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. |
Countries
Italy
Contacts
Primary ContactRaul Pellini, Doctor
Outcome results
None listed