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

Recruiting

• Conditions: Lymph Node Metastasis; High-risk Human Papillomavirus Infection; Liquid Biopsy; Carcinomas of Unknown Primary Site; Occult Tumor of the Head and Neck Area; Squamous Cell Carcinoma of the Oropharynx
• Interventions: Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

• Registration Number: NCT05918510
• Lead Sponsor: Regina Elena Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2023-03-29
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-04-04
• Study Completion: 2029-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx	Control group
Group 1	Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx	High miR value

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy