SURVEILLE-HPV National, Multicenter, Open-label, Randomized Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers

What this Trial Is About

Researchers are evaluating a new strategy for post-treatment monitoring of patients with HPV-positive oropharyngeal cancer, a type of throat cancer. This approach uses a blood test measuring HPV16 circulating DNA (HPV16 Ct-DNA) to detect possible cancer recurrence. The study aims to improve follow-up care by tailoring surveillance based on HPV status, potentially reducing unnecessary visits and identifying relapses early. This is a phase II, randomized, open-label trial sponsored by UNICANCER. Participants are assigned to either a standard follow-up group or an experimental group with fewer visits but regular HPV16 Ct-DNA testing. The standard group undergoes physical exams every 2 to 6 months over five years, with annual chest CT scans for certain smokers. The experimental group has physical exams combined with HPV16 Ct-DNA blood tests at specific months post-treatment and similar annual chest CT scans. If HPV16 Ct-DNA is detected, additional imaging and biopsy may be performed to confirm recurrence, guiding further care. During the study, participants will have scheduled physical exams, blood tests for HPV16 Ct-DNA, and imaging scans. Researchers will monitor the accuracy of HPV16 Ct-DNA in predicting recurrence, disease-free survival, survival rates, and cost-effectiveness over up to 5.5 years. This includes regular follow-ups to track relapse timing and survival outcomes. The total participation duration can extend up to five years after treatment, with close clinical and radiological assessments as needed based on test results.

SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers