Blood Biomarkers Based Screening for HPV-driven OPC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUNICANCER
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥50 years from the general population
Man
No previous history of HPV-driven cancer or head neck cancer
Willingness to complete follow up visits
Disqualifiers
Aged < 50 years
Woman
History of HPV-driven cancer or head and neck cancer
Psychiatric conditions
Trial design
Design model
Single group
Treatments tested in this trial
HPV16-E6 serology and HPV ctDNA
Diagnostic testIn 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.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Early identification of HPV-driven OPC lesions
The efficacy of this stepwise, biomarker-based screening approach to identify and treat early HPV-driven OPC lesions in asymptomatic individuals at high risk is determined by the number (and percentage) of participants who are positive for both HPV EA serology and HPV ctDNA, AND who have a successful identification of a tumor lesion.
Time frame
3 months following last prophylactic surgeryLocations
Source ClinicalTrials.gov
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