OncoMatch/Clinical Trials/NCT05582122
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
Is NCT05582122 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HPV16 Ct-DNA dosing for oropharynx squamous cell carcinoma.
Treatment: HPV16 Ct-DNA dosing — 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)
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CDKN2A overexpression (p16 positive)
p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
Required: HPV16 circulating DNA detected (Ct-DNA positive)
Positive HPV16 Ct-DNA measured before curative anticancer treatment
Required: HPV16 circulating DNA undetectable after treatment (Ct-DNA undetectable)
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).
Disease stage
Required: Stage T1-4, N0-3, I, II, III
Clinical stage T1-4, N0-3, M0 (stages I-III)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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