Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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

Study details

Head and Neck Tumors

NCT06224166

Regina Elena Cancer Institute

29 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.