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
- Conditions
- Oropharynx Squamous Cell Carcinoma
- Registration Number
- NCT05582122
- Lead Sponsor
- UNICANCER
- Brief 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. 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
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Patient aged 18 years or over
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Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
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Clinical stage T1-4, N0-3, M0 (stages I-III)
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Any tobacco status
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Life expectancy greater than 36 months
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Positive HPV16 Ct-DNA measured before curative anticancer treatment
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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).
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Patient must be affiliated to a Social Security System (or equivalent)
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Negative Predictive Value (NPV) of HPV16 ct-DNA 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.
- Secondary Outcome Measures
Name Time Method Rate of relapses detected by HPV16 ct-DNA 5.5 years The proportion of patients with relapse detected by HPV16 ct-DNA without any other symptoms.
Overall survival 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 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.
Loco-Regional recurrence 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 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.
5- year Negative Predictive Value 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 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.
Disease-free survival 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.
Trial Locations
- Locations (16)
Clinique St Vincent- Réunion
🇫🇷Saint-Denis, La Réunion, France
ISC Avignon
🇫🇷Avignon, France
Georges-François Leclerc
🇫🇷Dijon, France
Oscar Lambret- Lille
🇫🇷Lille, France
La Timone-AP-HM Marseille
🇫🇷Marseille, France
Antoine Lacassagne - NICE
🇫🇷Nice, France
CHU De Nîmes ICG
🇫🇷Nîmes, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Institut Curie - Paris
🇫🇷Paris, France
TENON - APHP Paris
🇫🇷Paris, France
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