Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Tumors
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Istituti Tumori Giovanni Paolo II
First posted: 2024-01-25
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from head and neck tumors, recruited in a manner consecutive among those who underwent surgery at the ENT UOC of the IRE between January 2019 and December 2021 and for which, at the start of the study, archive samples as well as i follow-up data up to at least one year after surgery. The biological samples of the cohort selected include both fresh tissue and liquid biopsy (blood and saliva) samples.

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.

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

Primary outcomes:
measure: Identification of biomarkers
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate HPV-DNA expression as biomarkers.
timeFrame: 24 months
measure: Evaluate miRNA expression as biomarkers
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Giovanni Blandino, Doctor
role: PRINCIPAL_INVESTIGATOR
References: