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

NCT ID: NCT06224166

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 283 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2025-01-17

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age over 18 years
• Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx
• Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
• Availability of material (tissue) and follow-up data for at least one year (retrospective part)
• Written informed consent (prospective part/patients in follow-up

Exclusion Criteria

• Presence of distant metastases at the time of diagnosis
• Previous head and neck cancer+
• Second cancer under treatment or follow-up for less than 5 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

Istituti Tumori Giovanni Paolo II

NETWORK

Sponsor Role: collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Blandino, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Blandino, Doctor

Role: CONTACT

giovanni.blandino@ifo.it

06 52662911 ext. +39

Facility Contacts

Giovanni Blandino, Doctor

Role: primary

giovanni.blandino@ifo.it

06 52662911

Other Identifiers

RS1826/23

Identifier Type: -

Identifier Source: org_study_id