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

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05918510

Run by

Regina Elena Cancer Institute

People needed

142

Starts

2022-04-04

Expected to finish

2029-04-04

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• "Regina Elena" National Cancer Institute — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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