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Blood Biomarkers Based Screening for HPV-driven OPC
Sponsor: UNICANCER
Summary
The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and/or whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.
Official title: SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2026-01
Completion Date
2032-01
Last Updated
2025-09-19
Healthy Volunteers
Yes
Interventions
HPV16-E6 serology and HPV ctDNA
In the event of a malignant lesion identified on clinical examination and/or imaging, treatment will be performed according to the standard of care. In the absence of any suspicious lesion, but in the event of HPV ctDNA positivity, prophylactic surgery of the tonsils and base of the tongue (the vast majority of HPV-related OPC develop in these regions) will be proposed to the patient, given the high risk of OPC. In case of refusal of this prophylactic surgery, close clinical and imaging monitoring will be performed. Surgical specimens will be analyzed to confirm or not the presence of HPV-driven OPC and HPV ctDNA will be measured post-operatively to ensure disease clearance.