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Blood Biomarkers Based Screening for HPV-driven OPC

SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528353
Acronym
SCREEN-HPV
Enrollment
10000
Registered
2024-07-30
Start date
2026-09-01
Completion date
2032-09-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer, Head and Neck Squamous Cell Carcinoma, Human Papilloma Virus

Keywords

HPV-induced cancer, Head and Neck Cancers, virology, serology, secondary cancer prevention

Brief 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.

Detailed description

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: * Antibodies directed against a specific protein of HPV called HPV16-E6 are present in most cases of HPV-related OPC and it has been shown that they can, be detected several years before the cancer diagnosis. * HPV ctDNA can be found in the blood of almost all patients with HPV-related cancers. After treatment, HPV ctDNA can detect relapses before they are visible on imaging tests (microscopic disease) We propose to test the use of these two blood tests to identify individuals at high risk of developing OPC and offer them appropriate medical follow-up. HPV16-E6 serology will be conducted on 10,000 men over 50 years of age without symptoms who have consented to participate in the project. These participants will be included during routine visits to the biomedical analysis laboratory. 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.

Interventions

DIAGNOSTIC_TESTHPV16-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.

Sponsors

UNICANCER
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Aged \< 50 years * Woman * History of HPV-driven cancer or head and neck cancer * Psychiatric conditions * Inability to complete follow up visits * Severe medical condition (life expectancy \<5 years) * Previous prophylactic HPV vaccination

Design outcomes

Primary

MeasureTime frameDescription
Early identification of HPV-driven OPC lesions3 months following last prophylactic surgeryThe 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.

Contacts

CONTACTMichaël CHEVROT
m-chevrot@unicancer.fr0171936161
PRINCIPAL_INVESTIGATORHaïtham Mirghani

APHP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026