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

NCT05918510 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2023-10-10

No results posted yet for this 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.

Conditions

  • Squamous Cell Carcinoma of the Oropharynx
  • Carcinomas of Unknown Primary Site
  • High-risk Human Papillomavirus Infection
  • Liquid Biopsy
  • Lymph Node Metastasis
  • Occult Tumor of the Head and Neck Area

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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    collaborator OTHER

  • Istituto Europeo di Oncologia

    collaborator OTHER

  • Azienda Policlinico Umberto I

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • University of Firenze and Siena, Napoli, Italy

    collaborator OTHER

  • Weizmann Institute of Science

    collaborator OTHER

  • Regina Elena Cancer Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2024-04-04
Completion
2029-04-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918510 on ClinicalTrials.gov