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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HPV16 Ct-DNA dosing

Treatment groups

420 Participants
are divided into 2 treatment groups

Locations

16
Clinique St Vincent- Réunion Saint-DenisLa Réunion, France
ISC Avignon Avignon France
Georges-François Leclerc Dijon France
Oscar Lambret- Lille Lille France

Sponsors and collaborators

UNICANCER

Lead sponsor