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Recruiting NCT05918510

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

— Observational Squamous Cell Carcinoma of the Oropharynx Carcinomas of Unknown Primary Site High-risk Human Papillomavirus Infection Liquid Biopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of the Oropharynx, Carcinomas of Unknown Primary Site, High-risk Human Papillomavirus Infection, Liquid Biopsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
    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 outcome measures

  • Accouracy [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • "Regina Elena" National Cancer Institute — Rome

Identifiers

NCT: NCT05918510 · RS1647/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗