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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Treatment groups

142 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Regina Elena Cancer Institute

Lead sponsor

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