Evaluating biomarkers for HPV-related throat cancer
New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
This study is trying to find new markers in patients with HPV-related throat cancer that can help predict how the disease will progress and respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06097936 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new prognostic and predictive biomarkers for HPV-associated oropharyngeal cancer (OPC) by evaluating the expression of HPV16-specific E5 transcripts in a cohort of patients. It includes a retrospective analysis of patients with at least two years of follow-up data and a prospective component involving a control group from outpatient clinics. The study seeks to clarify the role of HPV16-E5 in identifying potentially transformative infections related to HPV.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients over 18 years old who are current or former smokers and have had at least five lifetime oral sex partners.
Not a fit: Patients with oral pathology or those unable to understand and sign an informed consent form may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for patients with HPV-associated oropharyngeal cancer.
How similar studies have performed: While the specific approach of evaluating HPV16-E5 transcripts may be novel, similar studies have shown promise in identifying biomarkers for HPV-related cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male subjects * age \> 18 years * current and/or former smokers * reporting at least 5 (Souza 2017) lifetime oral sex partners * Written informed consent Exclusion Criteria: * Oral pathology * inability to understand and sign an informed consent form
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
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.