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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 142

Contacts and Locations

• Study Contact: Name: Raul Pellini, Doctor; Phone Number: 06-52664484; Email: raul.pellini@ifo.gov.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Raul Pellini, MD; Phone Number: ND; Email: raul.pellini@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; High miR value	Diagnostic test: Study 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.
Group 2; Control group	Diagnostic test: Study 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Weizmann Institute of Science; Istituto Clinico Humanitas; Azienda Policlinico Umberto I; Istituto Europeo di Oncologia; University of Firenze and Siena, Napoli, Italy

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): April 4, 2024
• Study Completion (Estimated): April 4, 2029

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: HPV Infection; Occult Cancer; Oropharyngeal Tumor; head-neck area
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; DNA Virus Infections; Neoplastic Processes; Tumor Virus Infections; Neoplasm Metastasis; Neoplasms, Squamous Cell; Urogenital Diseases; Genital Diseases; Head and Neck Neoplasms; Carcinoma; Lymphatic Metastasis; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: RS1647/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No