Clinical trial · Observational
Post-treatment Surveillance in HPV+ Oropharyngeal SCC
Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
NCT04965792CI-TRIAL-00115328active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV | — | UNRESOLVED | — |
| Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients
- description
- Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA.
- interventionNames
- Other: Screening
Primary outcomes (1)
- measure
- Recurrent disease Rate
- timeFrame
- Up to 5 years
- description
- The proportion of patients with recurrence first detected by ctHPV DNA will be calculated as a percentage and 95% confidence intervals (CI) established using binomial exact calculation.
Secondary outcomes (6)
- measure
- Recurrence Detection Predictive Properties
- timeFrame
- Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node) * HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods * Age 18 years or older * Will undergo oropharyngeal cancer treatment with curative intent * Ability to understand and the willingness to sign a written informed consent document. * Baseline positive or detectable ctHPV DNA result in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment Exclusion Criteria: * Distant metastatic disease (M1, AJCC 8th edition)
References
Publications (1)
- RESULTRettig EM, Schoenfeld JD, Miller J, Sargent B, Carey E, Margalit DN, Sehgal K, Sethi RKV, Uppaluri R, Tishler RB, Goguen LA, Annino DJ, Sim ES, Jo VY, Wong KS, Guenette JP, Haddad RI, Hanna GJ. A Prospective Trial of Biomarker-Guided Surveillance for HPV-Positive Oropharynx Cancer Using Plasma Tumor Tissue-Modified Viral HPV DNA. Clin Cancer Res. 2025 May 1;31(9):1605-1614. doi: 10.1158/1078-0432.CCR-24-3053. PMID 39715483