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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
Sponsor: UNICANCER
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)
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2024-04-03
Completion Date
2031-04-01
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
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.
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
Eugène Marquis-Rennes
Rennes, France
ICO - Site St Herblain
Saint-Herblain, France
ICANS Strasbourg
Strasbourg, France
IUCT Oncopole Toulouse
Toulouse, France
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, France