An interventional study of HPV16-E6 serology and HPV ctDNA in Head and Neck Squamous Cell Carcinoma, Anal Cancer and Human Papilloma Virus, sponsored by UNICANCER. Not yet recruiting. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by UNICANCER · Not applicable, Interventional, and Screening
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.
OPC caused by HPV are the most common head and neck cancers and are expected to increase in the future, especially since HPV vaccines are not widely used. Currently, there are no screening strategy available for these cancers, but developing such approaches could enable the earlier management of patients and thus improve prognosis while reducing treatment related toxicities.
Traditional screening methods like imaging or examination are not effective for OPC because early lesions are undetectable. However, studies suggest that using certain blood tests to detect HPV-related OPC early might be efficient:
Individuals positive for HPV16-E6 test will be contacted (approximately 100 participants). They will be offered to continue the study to receive an initial assessment and regular monitoring for 5 years (HPV ctDNA test, regular clinical examinations, imaging examinations if needed). In case of identification of suspicious lesions, appropriate management will be proposed according to the standard recommendations. If no lesion is detected but HPV ctDNA remains positive, preventive surgery may be considered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →UNICANCER is the lead sponsor of 219 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the first 500 participants enrolled, one additional blood sample will be drawn in DNA-free tubes for HPV ctDNA analysis. As we expect to have around 1% seropositive cases, most of these 500 samples will be seronegative and will constitute our control group. These controls will be tested for HPV ctDNA to confirm that seronegative participants are also HPV ctDNA-negative
Diagnostic Test: HPV16-E6 serology and HPV ctDNA
Individuals who are seropositive for HPV16-E6 will be contacted to propose the participation in the second part of the study and benefit from specific assessment and monitoring for 5 years (HPV ctDNA testing, regular clinical examinations of the head \& neck and anal-genital regions, imaging if needed).
Diagnostic Test: 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.
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 surgery
No study locations are listed for this record.
Plan to share: No — Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2032, 72 months later.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 72 months is above that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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