Multicenter evaluation of blood-based biomarkers for the detection of endometriosis and adenomyosis: A prospective non-interventional study.
Burghaus S., Drazic P., Wölfler M., Mechsner S., Zeppernick M., Meinhold-Heerlein I., Mueller MD., Rothmund R., Vigano P., Becker CM., Zondervan KT., Beckmann MW., Fasching PA., Berner-Gatz S., Grünewald FS., Hund M., Kastner P., Klammer M., Laubender RP., Wegmeyer H., Wienhues-Thelen U-H., Renner SP.
OBJECTIVE: To evaluate blood-based biomarkers to detect endometriosis and/or adenomyosis across nine European centers (June 2014-April 2018). METHODS: This prospective, non-interventional study assessed the diagnostic accuracy of 54 blood-based biomarker immunoassays in samples from 919 women (aged 18-45 years) with suspicion of endometriosis and/or adenomyosis versus symptomatic controls. Endometriosis was stratified by revised American Society for Reproductive Medicine stage. Symptomatic controls were "pathologic symptomatic controls" or "pathology-free symptomatic controls". The main outcome measure was receiver operating characteristic-area under the curve (ROC-AUC) and Wilcoxon P values corrected for multiple testing (q values). RESULTS: CA-125 performed best in "all endometriosis cases" versus "all symptomatic controls" (AUC 0.645, 95% confidence interval [CI] 0.600-0.690, q