Actively Recruiting

Age: 18Years +
All Genders
NCT05918510

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

Led by Regina Elena Cancer Institute · Updated on 2023-10-10

142

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

Sponsors

R

Regina Elena Cancer Institute

Lead Sponsor

I

Istituto Clinico Humanitas

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Squamous cell carcinomas of the oropharynx and occult tumors with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT
  • Age over 18 years
  • ECOG performance status 0, 1, or 2
  • Ability to follow study procedures and complete questionnaires
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of distant metastases at the time of diagnosis
  • Previous cancer of the head and neck area
  • Second tumor in therapy or follow-up for less than 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

"Regina Elena" National Cancer Institute

Rome, Italy, 00144

Actively Recruiting

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Research Team

R

Raul Pellini, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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