Oropharynx Squamous Cell CarcinomaPhase 2SURVEILLE-HPVNCT05582122
SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
A Phase 2 study testing HPV16 Ct-DNA dosing in people with Oropharynx Squamous Cell Carcinoma, run by UNICANCER at 16 sites in France.
Trial summary
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures. HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Squamous Cell Carcinoma
- What is being tested?
- HPV16 Ct-DNA dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 16 sitesFrance
- Study dates
- 3 Apr 2024to 1 Apr 2031
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or over
- Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
- Clinical stage T1-4, N0-3, M0 (stages I-III)
- Any tobacco status
- Life expectancy greater than 36 months
- Positive HPV16 Ct-DNA measured before curative anticancer treatment
Show all 13Show fewer
- Treated by any curative treatment
- Complete response at 3 months after end of treatment, which means:
- Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or
- Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or
- Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1).
- Patient must be affiliated to a Social Security System (or equivalent)
- Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his/her written consent, a trusted person of his/her choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent.
Who cannot join
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
- Any other HPV induced cancer within 5 years
- Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding
- Patient unwilling or unable to comply with the study protocol and follow-up schedule.
- Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication).
- Patient deprived of liberty or placed under protective custody or guardianship.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites, 13 recruiting
- Recruiting
ISC Avignon
Avignon
Benoit CALDERON, 04 90 27 62 74, b.calderon@isc84.org
- Recruiting
Georges-François Leclerc
Dijon
David THIBOUW, 03 70 63 23 23, dthibouw@cgfl.fr
- Not yet recruiting
Oscar Lambret- Lille
Lille
Samia BOUHIR, 03 20 29 59 59, s.bouhir@o-lambret.fr
- Recruiting
La Timone-AP-HM Marseille
Marseille
Sébastien SALAS, 04 91 38 57 08, sebastien.salas@ap-hm.fr
- Active, not recruiting
Antoine Lacassagne - NICE
Nice
- Active, not recruiting
CHU De Nîmes ICG
Nîmes
- Recruiting
Hôpital Européen Georges Pompidou
Paris
Haïtham MIRGHANI, 01 56 09 34 53, haitham.mirghani@aphp.fr
- Not yet recruiting
Institut Curie - Paris
Paris
Joey MARTIN, 06 89 65 30 29, joey.martin@curie.fr
- Recruiting
TENON - APHP Paris
Paris
Bertrand BAUJAT, 01 56 01 64 17, bertrand.baujat@aphp.fr
- Recruiting
Eugène Marquis-Rennes
Rennes
Florian ESTRADE, 02 99 25 31 82, f.estrade@rennes.unicancer.fr
- Active, not recruiting
Clinique St Vincent- Réunion
Saint-Denis, La Réunion
- Not yet recruiting
ICO - Site St Herblain
Saint-Herblain
Mélanie DORE, 02 40 67 99 00, melanie.dore@ico.unicancer.fr
- Recruiting
ICANS Strasbourg
Strasbourg
Mickaël BURGY, 03 68 76 71 15, m.burgy@icans.eu
- Recruiting
IUCT Oncopole Toulouse
Toulouse
Anouchka MODESTO, 05 31 15 54 29, modesto.anouchka@iuct-oncopole.fr
- Recruiting
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy
Romina MASTRONICOLA, 03 83 59 83 04, r.mastronicola@nancy.unicancer.fr
- Recruiting
Gustave Roussy
Villejuif
Pierre BLANCHARD, 01 42 11 53 60, Pierre.BLANCHARD@gustaveroussy.fr
About this study
Official title: SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.
HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status.
Read more
HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS.
The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA.
If confirmed, this new strategy could have several benefits including:
- reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and
- Identification of relapse at early stages (before the occurrence of symptoms)
- Conditions
- Oropharynx Squamous Cell Carcinoma
- Being tested
- HPV16 Ct-DNA dosing
- Keywords
- HPV16, CtDNA
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV16 Ct-DNA dosingBiological
Droplet based digital PCR (ddPCR) technology is a novel method for performing digital PCR. A sample is fractionated into 20,000 droplets, PCR amplification of the template molecules occurs in each individual droplet.
ddPCR allows to generate quantitative and accurate data without standard curves and also present higher sensitivity compared to conventional quantitative PCR (qPCR). Indeed, this method is based on the realization of millions of single-molecule PCRs in parallel in independent compartment (here droplets of an emulsion) and consequently avoids the bias seen in conventional PCR.
ddPCR offers an optimized approach for the sensitive detection and quantification of low-target-abundance biological samples.
DNA extraction will be planned on 1 mL of plasma, which will further increase the sensitivity of our technique initially based on only 200µL of DNA extracted plasma.
| Study group | Role | What they receive |
|---|---|---|
| Standard follow-up monitoring (16 visits over 5 years) | No intervention | Patients enrolled in the control arm will be monitored according to SFORL guidelines. Physical Examination (PE) will be carried out: - every 2 months the 1st year, every 3 months the 2nd year, every 4 months the 3rd year, every 6 months at 4 and 5 years. Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago. |
| Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing | Experimental | Physical Examinations (with HPV16 Ct-DNA dosing) planned at Months 4,8,12,18,24,30,36,48,60 post treatment.
Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago.
Any patient with a normal PE but positive HPV16 ct-DNA test during follow-up period will require a confirmation test ~1-2 months later.
If HPV16 ct-DNA positivity is confirmed, an H\&N MRI /PET-CT will be performed. Then:
* If MRI and PET-CT are negative, the patient will be examined every 2 months (PE and HPV16 Ct-DNA dosing) and MRI/PET-CT will be repeated every 4-6 months, until HPV16 Ct-DNA becomes undetectable.
* If MRI and/or PET-CT is positive, the patient will get a biopsy to confirm disease recurrence. Once confirmed, the patient will have the necessary care, as per local practices, but will continue to be followed up within this study up to 5 years after treatment. Receives: Biological: HPV16 Ct-DNA dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value (NPV) of HPV16 ct-DNA
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
Measured: 24 months
Secondary outcomes (8)
5- year Negative Predictive Value
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
Measured: 48 and 60 months
Positive Predictive Value (PPV) of HPV16 ct-DNA
The presence of HPV16 ct-DNA will be evaluated by ddPCR. PPV will be defined as 2 successive HPV16 ct-DNA positive results.
Measured: 18, 24, 48, and 60 months
Rate of relapses detected by HPV16 ct-DNA
The proportion of patients with relapse detected by HPV16 ct-DNA without any other symptoms.
Measured: 5.5 years
Disease-free survival
Disease-free survival (DFS) is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Measured: 5.5 years
Loco-Regional recurrence
Evaluation of the stage of the first loco-regional event detected by medical imaging. The stage will be defined by the size of the tumor and the number of invaded lymph nodes.
Measured: From randomization to disease recurrence, up to 5.5 years
Time of distant recurrence
The length of time until manifestation of the first metastatic event detected by medical imaging.
Measured: From randomization to disease recurrence, up to 5.5 years
Overall survival
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Measured: From randomization to death from any cause, up to 5.5 years
Cost-effectiveness analysis of the proposed strategy
To evaluate the economic cost of the lightened surveillance as compared to the standard treatment in terms of cost assessments and incremental cost-effectiveness ratio.
Measured: 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start3 Apr 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582122
- Sponsor's protocol ID
- UC-HNG-2209
- Acronym
- SURVEILLE-HPV
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
- ClinicalTrials.gov ID
- NCT05582122
- Acronym / sponsor ID
- SURVEILLE-HPV / UC-HNG-2209
- Conditions
- Oropharynx Squamous Cell Carcinoma
- Keywords
- HPV16, CtDNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 17 Oct 2022 (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.
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.
HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status.
HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS.
The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA.
If confirmed, this new strategy could have several benefits including:
- reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and
- Identification of relapse at early stages (before the occurrence of symptoms)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard follow-up monitoring (16 visits over 5 years) | No intervention | –Patients enrolled in the control arm will be monitored according to SFORL guidelines. Physical Examination (PE) will be carried out: - every 2 months the 1st year, every 3 months the 2nd year, every 4 months the 3rd year, every 6 months at 4 and 5 years. Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago. |
| Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing | Experimental | Biological: HPV16 Ct-DNA dosingPhysical Examinations (with HPV16 Ct-DNA dosing) planned at Months 4,8,12,18,24,30,36,48,60 post treatment. Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago. Any patient with a normal PE but positive HPV16 ct-DNA test during follow-up period will require a confirmation test ~1-2 months later. If HPV16 ct-DNA positivity is confirmed, an H\&N MRI /PET-CT will be performed. Then: * If MRI and PET-CT are negative, the patient will be examined every 2 months (PE and HPV16 Ct-DNA dosing) and MRI/PET-CT will be repeated every 4-6 months, until HPV16 Ct-DNA becomes undetectable. * If MRI and/or PET-CT is positive, the patient will get a biopsy to confirm disease recurrence. Once confirmed, the patient will have the necessary care, as per local practices, but will continue to be followed up within this study up to 5 years after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient aged 18 years or over
- Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
- Clinical stage T1-4, N0-3, M0 (stages I-III)
- Any tobacco status
- Life expectancy greater than 36 months
Key exclusion criteria (7 listed)
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
- Any other HPV induced cancer within 5 years
- Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding
- Patient unwilling or unable to comply with the study protocol and follow-up schedule.
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 Ct-DNA dosingDroplet based digital PCR (ddPCR) technology is a novel method for performing digital PCR. A sample is fractionated into 20,000 droplets, PCR amplification of the template molecules occurs in each individual droplet. ddPCR allows to generate quantitative and accurate data without standard curves and also present higher sensitivity compared to conventional quantitative PCR (qPCR). Indeed, this method is based on the realization of millions of single-molecule PCRs in parallel in independent compartment (here droplets of an emulsion) and consequently avoids the bias seen in conventional PCR. ddPCR offers an optimized approach for the sensitive detection and quantification of low-target-abundance biological samples. DNA extraction will be planned on 1 mL of plasma, which will further increase the sensitivity of our technique initially based on only 200µL of DNA extracted plasma. | Biological | Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing |
Primary outcome
Negative Predictive Value (NPV) of HPV16 ct-DNA
Time frame: 24 months
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
8 secondary outcomes
5- year Negative Predictive Value
Time frame: 48 and 60 months
Positive Predictive Value (PPV) of HPV16 ct-DNA
Time frame: 18, 24, 48, and 60 months
Rate of relapses detected by HPV16 ct-DNA
Time frame: 5.5 years
Disease-free survival
Time frame: 5.5 years
Loco-Regional recurrence
Time frame: From randomization to disease recurrence, up to 5.5 years
Time of distant recurrence
Time frame: From randomization to disease recurrence, up to 5.5 years
Overall survival
Time frame: From randomization to death from any cause, up to 5.5 years
Cost-effectiveness analysis of the proposed strategy
Time frame: 5.5 years
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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPV16 Ct-DNA dosing in people with Oropharynx Squamous Cell Carcinoma, run by UNICANCER at 16 sites in France.
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 13 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Predictive Value (NPV) of HPV16 ct-DNA (time frame: 24 months). 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 19 Sep 2025.