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Purpose <p>The primary objective is to determine the positive predictive value (PPV) of ctHPVDNA for diagnosis and recurrence. Secondary objectives include measuring the lead time between ctHPVDNA positivity and pathological recurrence.</p> Methods <p>ddPCR reactions were prepared with 2× ddPCR Supermix for Probes (No dUTP) (Bio-Rad) and assay-specific primers/probes targeting the E6/E7 region of HPV16, HPV33, and HPV35. Patients were included in the diagnosis cohort if they had at least one ctHPVDNA measurement obtained prior to the initiation of primary treatment. Patients were assigned to the surveillance cohort if they had at least one ctHPVDNA test performed following completion of definitive or salvage therapy.</p> Results <p>At diagnosis test revealed in 167 patients a PPV of 98,5% (95% CI, 94,6%-99,8%) and NPP of 97,1% (95% CI, 85,1%-99,9%). At follow up, ctHPVDNA testing demonstrated in 165 patients PPV of 96,9% (95% CI, 84,3%-99,4% [31 of 32 tests]), and NPV of 100% (95% CI, 98,9%-100% [351 of 351 tests]). There was a median lead time of positive test to event (recurrence day) of 44 days (range, 0-343 days) and mean (SD) of 143 (167,8) days. When we consider only the 11 patients enrolled at the time of the first diagnosis and followed with serial blood sampling, the median lead time was 331 days (range, 23-393 days) and mean (SD) of 233 (156,7) days.</p> Conclusion <p>ctHPVDNA represents a promising dynamic biomarker for diagnosis and Follow-up. Incorporation of ctHPVDNA kinetics into follow-up protocols may reduce reliance on frequent imaging, enabling a targeted follow-up strategy and allowing earlier detection of recurrence.</p>

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Explore the role of ctHPVDNA kinetics during diagnosis and follow-up of HPV OPSCC

  • 期刊论文

  • 发表日期：

    2026年2月24日

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  • Flaminia Campo,
  • Francesca Paolini,
  • Federica Rossi,
  • Eleonora Guido,
  • Debora Cacciato,
  • Antonello Vidiri,
  • Fulvia Pimpinelli,
  • Aldo Venuti,
  • Raul Pellini

摘要

Purpose

The primary objective is to determine the positive predictive value (PPV) of ctHPVDNA for diagnosis and recurrence. Secondary objectives include measuring the lead time between ctHPVDNA positivity and pathological recurrence.

Methods

ddPCR reactions were prepared with 2× ddPCR Supermix for Probes (No dUTP) (Bio-Rad) and assay-specific primers/probes targeting the E6/E7 region of HPV16, HPV33, and HPV35. Patients were included in the diagnosis cohort if they had at least one ctHPVDNA measurement obtained prior to the initiation of primary treatment. Patients were assigned to the surveillance cohort if they had at least one ctHPVDNA test performed following completion of definitive or salvage therapy.

Results

At diagnosis test revealed in 167 patients a PPV of 98,5% (95% CI, 94,6%-99,8%) and NPP of 97,1% (95% CI, 85,1%-99,9%). At follow up, ctHPVDNA testing demonstrated in 165 patients PPV of 96,9% (95% CI, 84,3%-99,4% [31 of 32 tests]), and NPV of 100% (95% CI, 98,9%-100% [351 of 351 tests]). There was a median lead time of positive test to event (recurrence day) of 44 days (range, 0-343 days) and mean (SD) of 143 (167,8) days. When we consider only the 11 patients enrolled at the time of the first diagnosis and followed with serial blood sampling, the median lead time was 331 days (range, 23-393 days) and mean (SD) of 233 (156,7) days.

Conclusion

ctHPVDNA represents a promising dynamic biomarker for diagnosis and Follow-up. Incorporation of ctHPVDNA kinetics into follow-up protocols may reduce reliance on frequent imaging, enabling a targeted follow-up strategy and allowing earlier detection of recurrence.