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

Last updated: October 6, 2023
Sponsor: Regina Elena Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Clinical Study ID

NCT05918510
RS1647/22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph nodemetastases laterocervical cytologically positive for squamous cell carcinoma treatedwith 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

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 Design

Total Participants: 142
Treatment Group(s): 1
Primary Treatment: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
Phase:
Study Start date:
April 04, 2022
Estimated Completion Date:
April 04, 2029

Connect with a study center

  • "Regina Elena" National Cancer Institute

    Rome, 00144
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.