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.

Recruiting

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Key information

Conditions

Squamous Cell Carcinoma of the Oropharynx Carcinoma Carcinoma, Squamous Cell Carcinomas of Unknown Primary Site Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Head and Neck Neoplasms High-risk Human Papillomavirus Infection Infections Liquid Biopsy Lymph Node Metastasis Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Occult Tumor of the Head and Neck Area Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

Location contact

Raul Pellini, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Accouracy

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raul Pellini, Doctor

CONTACT

[email protected]

06-52664484

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

Azienda Policlinico Umberto I
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Istituto Clinico Humanitas
Istituto Europeo di Oncologia
University of Firenze and Siena, Napoli, Italy
Weizmann Institute of Science

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2029
First posted: Jun 26, 2023
Registry last updated: Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting