NCT06224166

Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 283 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.

Detailed description

For each patient they will come collected tissue, blood and saliva samples. In particular, as regards tissue collection, tumor and neighboring tissues will be used healthy specimens taken during surgical removal, according to clinical practice. The fresh tissues thus collected will be stored in RNA-later before freezing at - 80°C. Furthermore, blood and saliva samples will be taken at different times, in particular: i) the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the patient's follow-up (FU): every 3 months for the first 2 years and every 6 months for the following 3 years. The samples will then be used to carry out nucleic acid extraction, the DNA will instead be used to detect the presence of HPV.

Conditions

• Head and Neck Tumors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Collection and use of tissue samples, blood and saliva	For tissue collection, tumor and surrounding tissues will be used healthy specimens taken during surgical removal, according to clinical practice. Blood and saliva sampling will be carried out at different times: i) the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the follow-up (FU)

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2024-01-25
• Last updated: 2024-01-26

Locations

1 site across 1 country: Italy