Non-invasive detection of head and neck cancer recurrence using biological fluids
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
This study is testing whether checking blood and saliva samples for certain markers can help find out if head and neck cancer has come back in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 283 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06224166 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze HPV and biomarkers in biological fluids from patients with head and neck tumors to develop a non-invasive method for detecting cancer recurrence. It involves collecting tissue, blood, and saliva samples from patients at various stages, including pre-surgery and during follow-up visits. The samples will be analyzed for the presence of HPV-DNA/RNA and miRNA, which may indicate tumor recurrence. The study is multicenter and includes both retrospective and prospective components.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with squamous cell tumors of the oral cavity, pharynx, or larynx who are undergoing surgical treatment.
Not a fit: Patients with distant metastases, previous head and neck cancers, or those currently undergoing treatment for a second cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more efficient method for monitoring head and neck cancer recurrence.
How similar studies have performed: Other studies have explored similar non-invasive methods for cancer detection, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni Blandino, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Giovanni Blandino, Doctor
- Email: giovanni.blandino@ifo.it
- Phone: 06 52662911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.