Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05918510

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

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
142 (estimated)
Sponsor
Regina Elena Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTStudy of Viral BIOmarkers and microRNAs in Tumors OrofarynxThe 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.

Timeline

Start date
2022-04-04
Primary completion
2024-04-04
Completion
2029-04-04
First posted
2023-06-26
Last updated
2023-10-10

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05918510. Inclusion in this directory is not an endorsement.