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

NCT06224166 | Unknown

• 1 other identifier: RS1826/23
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate HPV-DNA expression as biomarkers.

  24 months

• Evaluate miRNA expression as biomarkers

  24 months

Interventions

Collection and use of tissue samples, blood and saliva DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• University of Milan: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples, blood and saliva

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giovanni Blandino, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Blandino, Doctor

CONTACT

06 52662911; giovanni.blandino@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 17, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

IT (1)