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 (SURVEILLE-HPV)
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| ClinicalTrials.gov Identifier: NCT05582122 |
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Recruitment Status :
Recruiting
First Posted : October 17, 2022
Last Update Posted : April 15, 2024
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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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oropharynx Squamous Cell Carcinoma | Biological: HPV16 Ct-DNA dosing | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 420 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | April 3, 2024 |
| Estimated Primary Completion Date : | April 1, 2028 |
| Estimated Study Completion Date : | April 1, 2031 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard follow-up monitoring (16 visits over 5 years)
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. |
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Experimental: Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing
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:
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Biological: HPV16 Ct-DNA dosing
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. |
- 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.
- 5- year Negative Predictive Value [ Time Frame: 48 and 60 months ]The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
- Positive Predictive Value (PPV) of HPV16 ct-DNA [ Time Frame: 18, 24, 48, and 60 months ]The presence of HPV16 ct-DNA will be evaluated by ddPCR. PPV will be defined as 2 successive HPV16 ct-DNA positive results.
- Rate of relapses detected by HPV16 ct-DNA [ Time Frame: 5.5 years ]The proportion of patients with relapse detected by HPV16 ct-DNA without any other symptoms.
- Disease-free survival [ Time Frame: 5.5 years ]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.
- Loco-Regional recurrence [ Time Frame: From randomization to disease recurrence, up to 5.5 years ]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.
- Time of distant recurrence [ Time Frame: From randomization to disease recurrence, up to 5.5 years ]The length of time until manifestation of the first metastatic event detected by medical imaging.
- Overall survival [ Time Frame: From randomization to death from any cause, up to 5.5 years ]The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
- Cost-effectiveness analysis of the proposed strategy [ Time Frame: 5.5 years ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Treated by any curative treatment
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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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05582122
| France | |
| Clinique St Vincent- Réunion | Active, not recruiting |
| Saint-Denis, La Réunion, France | |
| ISC Avignon | Active, not recruiting |
| Avignon, France | |
| Georges-François Leclerc | Active, not recruiting |
| Dijon, France | |
| Oscar Lambret- Lille | Not yet recruiting |
| Lille, France | |
| Contact: Samia BOUHIR 03 20 29 59 59 s.bouhir@o-lambret.fr | |
| La Timone-AP-HM Marseille | Recruiting |
| Marseille, France | |
| Contact: Sébastien SALAS 04 91 38 57 08 sebastien.salas@ap-hm.fr | |
| Antoine Lacassagne - NICE | Not yet recruiting |
| Nice, France | |
| Contact: Dorian CULIE 04 92 03 17 89 dorian.culie@nice.unicancer.fr | |
| CHU De Nîmes ICG | Not yet recruiting |
| Nîmes, France | |
| Contact: Sophie BARGAS 04 66 68 33 01 sophie.bargas@chu-nimes.fr | |
| Hôpital Européen Georges Pompidou | Recruiting |
| Paris, France | |
| Contact: Haïtham MIRGHANI 01 56 09 34 53 haitham.mirghani@aphp.fr | |
| Institut Curie - Paris | Not yet recruiting |
| Paris, France | |
| Contact: Joey MARTIN 06 89 65 30 29 joey.martin@curie.fr | |
| TENON - APHP Paris | Recruiting |
| Paris, France | |
| Contact: Bertrand BAUJAT 01 56 01 64 17 bertrand.baujat@aphp.fr | |
| Eugène Marquis-Rennes | Recruiting |
| Rennes, France | |
| Contact: Florian ESTRADE 02 99 25 31 82 f.estrade@rennes.unicancer.fr | |
| ICO - Site St Herblain | Not yet recruiting |
| Saint-Herblain, France | |
| Contact: Mélanie DORE 02 40 67 99 00 melanie.dore@ico.unicancer.fr | |
| ICANS Strasbourg | Active, not recruiting |
| Strasbourg, France | |
| IUCT Oncopole Toulouse | Not yet recruiting |
| Toulouse, France | |
| Contact: Anouchka MODESTO 05 31 15 54 29 modesto.anouchka@iuct-oncopole.fr | |
| Institut de cancérologie de Lorraine | Not yet recruiting |
| Vandœuvre-lès-Nancy, France | |
| Contact: Romina MASTRONICOLA | |
| Gustave Roussy | Not yet recruiting |
| Villejuif, France | |
| Contact: Pierre BLANCHARD 01 42 11 53 60 Pierre.BLANCHARD@gustaveroussy.fr | |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT05582122 |
| Other Study ID Numbers: |
UC-HNG-2209 |
| First Posted: | October 17, 2022 Key Record Dates |
| Last Update Posted: | April 15, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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HPV16 CtDNA |
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Oropharyngeal Neoplasms Recurrence Neoplasms Disease Attributes Pathologic Processes Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |