Technical Verification and Assessment of Independent Validation of Biomarker Models for Endometriosis

Dorien F O, Amelie Fassbender, Rita van Bree, Annouschka Laenen, Daniëlle P Peterse, Daniëlle Peterse, Arne Vanhie, Etienne Waelkens, Thomas D’Hooghe
BioMed research international · 2019 · vol. 2019 , pp. 1–11 · doi:10.1155/2019/3673060 · PMID:31428634 · W2962821252
article OA: hybrid CC0 ⤵ 15 in-corpus citations
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Previously developed endometriosis biomarker models showed low performance upon technical verification and independent validation, prompting new models where only CA-125 was consistently retained.

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Abstract

There is a great need for a noninvasive diagnosis for endometriosis. Several biomarkers and biomarker panels have been proposed. Biomarker models consisting of CA-125, VEGF, Annexin V, and glycodelin/sICAM-1 were previously developed by our group. The objective of our current study was to assess the impact of technical and biological variability on the performance of those previously developed prediction models in a technical verification and a validation setting. The technical verification cohort consisted of peripheral blood plasma samples from a subset of the patients included in the original study of Vodolazkaia et al. (99 women with and 37 women without endometriosis). The validation study was done in plasma samples of an independent patient cohort (170 women with and 86 women without endometriosis). Single immunoassays were used for CA-125, VEGF-A, sICAM-1, Annexin V, and glycodelin. Statistical analyses were done using univariate and multivariate (logistic regression) approaches. The previously reported prediction models for endometriosis had a low performance in both the technical verification and validation setting. New prediction models were developed, which included CA-125, Annexin V, and sICAM-1, but CA-125 was the only marker that was retained in the models across the technical verification and validation study. Overall, successful validation of a biomarker model depends on several factors such as patient selection, collection methods, assay selection/handling, stability of the marker, and statistical analysis and interpretation. There is a need for standardized studies in large, well-defined patient cohorts with robust assay methodologies.

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Condition tags

mesh:D004715endometriosis

MeSH descriptors

Annexin A5 CA-125 Antigen Endometriosis Intercellular Adhesion Molecule-1 Models, Biological Adult Annexin A5 Biomarkers Biomarkers CA-125 Antigen Endometriosis Female Humans Intercellular Adhesion Molecule-1

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