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

R

Regina Elena Cancer Institute

Status

Enrolling

Conditions

Head and Neck Tumors

Treatments

Diagnostic Test: Collection and use of tissue samples, blood and saliva

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT06224166
RS1826/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

283 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Giovanni Blandino, Doctor

Data sourced from clinicaltrials.gov

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