Head and Neck Squamous Cell CarcinomaSCREEN-HPVNCT06528353
Blood Biomarkers Based Screening for HPV-driven OPC
A study testing HPV16-E6 serology and HPV ctDNA in people with Head and Neck Squamous Cell Carcinoma and Anal Cancer, run by UNICANCER.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Anal Cancer, Human Papilloma Virus
- What is being tested?
- HPV16-E6 serology and HPV ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC
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.
Read the 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.
- Being tested
- HPV16-E6 serology and HPV ctDNA
- Keywords
- HPV-induced cancer, Head and Neck Cancers, virology, serology, secondary cancer prevention
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Anus Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV16-E6 serology and HPV ctDNADiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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 Receives: Diagnostic Test: HPV16-E6 serology and HPV ctDNA |
| Experimental Group | Experimental | 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). Receives: Diagnostic Test: HPV16-E6 serology and HPV ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months following last prophylactic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haïtham Mirghani, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528353
- Sponsor's protocol ID
- ORL 16
- Acronym
- SCREEN-HPV
- Status last verified
- May 2026
- First submitted
- 25 Jul 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC
- ClinicalTrials.gov ID
- NCT06528353
- Acronym / sponsor ID
- SCREEN-HPV / ORL 16
- Keywords
- HPV-induced cancer, Head and Neck Cancers, virology, serology, secondary cancer prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Diagnostic Test: HPV16-E6 serology and HPV ctDNAFor 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 |
| Experimental Group | Experimental | Diagnostic Test: HPV16-E6 serology and HPV ctDNAIndividuals 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Aged < 50 years
- Woman
- History of HPV-driven cancer or head and neck cancer
- Psychiatric conditions
- Inability to complete follow up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV16-E6 serology and HPV ctDNAIn 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. | Diagnostic test | Control group, Experimental Group |
Primary outcome
Early identification of HPV-driven OPC lesions
Time frame: 3 months following last prophylactic surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haïtham Mirghani principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
A study testing HPV16-E6 serology and HPV ctDNA in people with Head and Neck Squamous Cell Carcinoma and Anal Cancer, run by UNICANCER.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaël CHEVROT (0171936161, m-chevrot@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early identification of HPV-driven OPC lesions (time frame: 3 months following last prophylactic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.