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

NCT05918510 | Recruiting

• 1 other identifier: RS1647/22
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oropharyngeal Tumor; Occult Cancer; HPV Infection; head-neck area

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

High miR value

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

Group 2

Control group

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

Interventions

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx DIAGNOSTIC_TEST

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 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

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

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Lymphatic Metastasis; Oropharyngeal Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes

Central Study Contacts

Raul Pellini, Doctor

CONTACT

06-52664484; raul.pellini@ifo.gov.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: June 26, 2023
• Study Start: April 4, 2022
• Primary Completion: April 4, 2024
• Study Completion (Estimated): April 4, 2029
• Last Updated: October 10, 2023

Record last verified: 2023-06

Locations

IT (1)