RecruitingNCT05918510

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


Sponsor

Regina Elena Cancer Institute

Enrollment

142 participants

Start Date

Apr 4, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting and analyzing tissue samples and blood markers from patients with throat cancer (oropharyngeal cancer) or hidden tumors in neck lymph nodes that are linked to the human papillomavirus (HPV). The researchers are studying specific biological markers — including microRNAs and viral signals — to better understand how these cancers behave and respond to treatment. **You may be eligible if:** - You are over 18 years old - You have been diagnosed with squamous cell carcinoma of the oropharynx (back of the throat, tonsils, or base of tongue) or a hidden primary tumor with HPV-positive lymph node involvement - You are scheduled to be treated with surgery, radiation, or chemoradiation - You are well enough to follow study procedures and complete questionnaires **You may NOT be eligible if:** - Your cancer has already spread to distant parts of the body (distant metastases) at the time of diagnosis - You have previously had a head or neck cancer - You have or have had a second cancer that is currently being treated or has been in follow-up for less than 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTStudy 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.


Locations(1)

"Regina Elena" National Cancer Institute

Rome, Italy

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NCT05918510


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