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

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Lymph Node Metastasis; Occult Tumor of the Head and Neck Area; High-risk Human Papillomavirus Infection; Squamous Cell Carcinoma of the Oropharynx; Liquid Biopsy; Carcinomas of Unknown Primary Site

Treatments: Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Study type: Observational

Funder types: Other

Identifiers

NCT05918510

RS1647/22

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

142 participants in 2 patient groups

Group 1

Description:

High miR value

Treatment:

Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Group 2

Description:

Control group

Treatment:

Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx