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

Head and Neck Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224166
• Other study ID #: RS1826/23
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: January 17, 2025

Study information

• Verified date: January 2024
• Source: Regina Elena Cancer Institute
• Contact: Giovanni Blandino, Doctor
• Phone: 06 52662911
• Email: giovanni.blandino[@]ifo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 283
• Est. completion date: January 17, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumors
• Recurrence

Intervention

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)

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Istituti Tumori Giovanni Paolo II, University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of biomarkers	The samples that will be collected in this study will be used to carry out nucleic acid extraction.; In particular, the extraction of RNA and DNA from tissue samples will be carried out using the "All prep RNA/DNA miRNA universal kit" kit (Qiagen), while from blood and saliva samples it will be carried out respectively through the use of the "DNAeasy blood and tissue kit" (Qiagen) and the "Magmax Total RNA extraction kit" (Thermofisher), following the instructions given in the relevant protocol.; The expression of tissue and circulating microRNAs will be evaluated by qRT-PCR analysis using the Taqman method (Life Technology), digital-PCR (dPCR) and Luminex platform (the latter at the IRCSS G Paolo II Tumor Institute of Bari). In particular, the use of dPCR will be necessary for those low-abundance circulating miRNAs which, with the qRT-PCR methodology, are not detectable.	24 months
Secondary	Evaluate HPV-DNA expression as biomarkers.	The DNA will be used to detect the presence of HPV and will be analyzed using dPCR and the Luminex platform. These methods are able to absolutely quantify the number of viral genomes present in the sample and also to evaluate the physical state of the virus: episomal, integrated or mixed..	24 months
Secondary	Evaluate miRNA expression as biomarkers	To identify the prognostic role of the 4 miRNAs in the liquid biopsy, the analysis of the expression of the same miRNAs in the tissue component, in order to evaluate their possible correlation.	24 months