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Predictive biomarkers for regression in women undergoing active surveillance for cervical intraepithelial neoplasia grade 2: A prospective multicenter study in Italy

  • 0Immunology and Diagnostic Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
International Journal of Cancer +

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August 30, 2025

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August 30, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

Cervical intraepithelial neoplasia grade 2 (CIN2) often regresses spontaneously. Biomarkers like HPV negativity, absence of p16/ki67, and unmethylated genes predict high regression probability, supporting active surveillance for women up to 45 years.

Area Of Science

  • Gynecology
  • Oncology
  • Virology

Background

  • Cervical intraepithelial neoplasia grade 2 (CIN2) exhibits significant spontaneous regression rates.
  • Identifying biomarkers for predicting CIN2 regression is crucial for optimizing management strategies.

Purpose Of The Study

  • To prospectively identify biomarkers associated with a high probability of CIN2 regression.
  • To evaluate the feasibility of active surveillance for CIN2 based on biomarker status.

Main Methods

  • A prospective multicenter cohort study enrolled 319 women aged 25-45 years with CIN2.
  • Evaluated biomarkers included HPV genotyping, p16/ki67 expression, and FAM19A4/miR124-2 methylation status.
  • Binomial logistic regression analyzed the association between biomarkers and CIN2 regression over 24 months.

Main Results

  • CIN2 regression, persistence, and progression were observed in 56%, 23%, and 21% of cases, respectively.
  • High probability of regression was significantly associated with early HPV negativity (OR 6.45), no p16/ki67 expression (OR 2.49), and unmethylated FAM19A4/miR124-2 genes (OR 2.12).
  • No significant association was found between age and regression rates.

Conclusions

  • Active surveillance for CIN2 is a viable option for women up to 45 years, particularly when selected using clinical criteria and biomarkers.
  • Sequential use of biomarkers, starting with HPV genotyping, can enhance the feasibility and accuracy of selecting patients for surveillance.

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