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Background <p>Nanoparticle immunoassays for CA125 and CA15-3 glycovariants are promising tools for epithelial ovarian cancer (EOC) and borderline ovarian tumor (BOT) early detection.</p> Method <p>This retrospective population-based study utilized prospective (&lt; 3 years) plasma samples from 110 cases and 440 controls. Sialyl-Thomsen-nouveau (STn) antibody and macrophage galactose-type lectin (MGL) to detect cancer antigen 125 (CA125) and 15 − 3 (CA15-3) glycoforms were evaluated, using CA125, CA15-3, and HE4 enzyme immunoassay (EIA) references. The area under the receiver operating characteristic curve (AUC), partial AUC (pAUC) at specificities 0.9–1.0, and sensitivity (SN) at 0.98 specificity (SP) for detecting EOC/BOT were calculated.</p> Results <p>The single marker with the highest point estimate for pAUC and SN at 98% SP was CA125<sup>EIA</sup> (pAUC 0.71 (0.66, 0.76), SN at 98% SP 0.29 (0.17–0.42 combinations)). The CA15-3<sup>STn</sup> + CA125<sup>EIA</sup> and CA125<sup>EIA</sup> + HE4<sup>EIA</sup> improved the detection rate point estimates and provided the highest pAUC values (CA125<sup>EIA</sup> + CA15-3<sup>STn</sup>: 0.75 (0.70–0.80); CA125<sup>EIA</sup> + HE4<sup>EIA</sup>: 0.71 (0.66–0.77)). For 0–&lt;1, 1–&lt;2 and 2–&lt;3 years lag time, CA125<sup>EIA</sup> and the CA125 glycovariants provided similar pAUC and SN at 98% SP, with largely overlapping confidence intervals.</p> Conclusion <p>This case-control study, which used plasma samples collected up to three years before diagnosis of EOC or BOT, did not provide evidence of a higher discriminatory capacity of the glycovariant biomarkers compared with the clinically established biomarker CA125<sup>EIA</sup> in asymptomatic women. Increased plasma volumes and larger cohorts are suggested in future studies.</p>

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Predictive ability of novel glycovariant biomarkers of CA125 and CA15-3 up to three years prior to ovarian cancer diagnosis: a population-based case-control study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月29日

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  • Hanna Roos Alexander,
  • Shamima Afrin Ruma,
  • Shruti Jain,
  • Eva Lundin,
  • Per Liv,
  • Pernilla Israelsson,
  • Kim Pettersson,
  • Annika Idahl

摘要

Background

Nanoparticle immunoassays for CA125 and CA15-3 glycovariants are promising tools for epithelial ovarian cancer (EOC) and borderline ovarian tumor (BOT) early detection.

Method

This retrospective population-based study utilized prospective (< 3 years) plasma samples from 110 cases and 440 controls. Sialyl-Thomsen-nouveau (STn) antibody and macrophage galactose-type lectin (MGL) to detect cancer antigen 125 (CA125) and 15 − 3 (CA15-3) glycoforms were evaluated, using CA125, CA15-3, and HE4 enzyme immunoassay (EIA) references. The area under the receiver operating characteristic curve (AUC), partial AUC (pAUC) at specificities 0.9–1.0, and sensitivity (SN) at 0.98 specificity (SP) for detecting EOC/BOT were calculated.

Results

The single marker with the highest point estimate for pAUC and SN at 98% SP was CA125EIA (pAUC 0.71 (0.66, 0.76), SN at 98% SP 0.29 (0.17–0.42 combinations)). The CA15-3STn + CA125EIA and CA125EIA + HE4EIA improved the detection rate point estimates and provided the highest pAUC values (CA125EIA + CA15-3STn: 0.75 (0.70–0.80); CA125EIA + HE4EIA: 0.71 (0.66–0.77)). For 0–<1, 1–<2 and 2–<3 years lag time, CA125EIA and the CA125 glycovariants provided similar pAUC and SN at 98% SP, with largely overlapping confidence intervals.

Conclusion

This case-control study, which used plasma samples collected up to three years before diagnosis of EOC or BOT, did not provide evidence of a higher discriminatory capacity of the glycovariant biomarkers compared with the clinically established biomarker CA125EIA in asymptomatic women. Increased plasma volumes and larger cohorts are suggested in future studies.