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      Influence of Pregnancy-Related Conditions on Human Epididymis Protein 4 Serum Levels in Comparison to CA 125 – a Prospective Cohort Trial Translated title: Auswirkungen von schwangerschaftsbedingten Erkrankungen auf den humanen Epididymis-Protein-4-Spiegel im Blut verglichen mit CA 125 – eine prospektive Kohortenstudie

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          Abstract

          Introduction HE4 and CA 125, two established biomarkers for assessing adnexal masses in non-pregnant women, are hardly investigated in pregnancy, especially in pregnancy-associated conditions. The aim was to evaluate HE4 and CA 125 levels in the course of pregnancy and to assess the impact of pregnancy disorders, contractions and rupture of membranes on HE4 and CA 125 serum levels in order to use these parameters for evaluation of adnexal masses in pregnancy.

          Patients and Methods Blood samples (n = 238) of 201 women seen at the Medical University of Innsbruck, Austria, were prospectively obtained during pregnancy and postpartum. Serum concentrations of HE4 and CA 125 were analyzed. ROMA index was calculated by the premenopausal formula.

          Results HE4 serum levels were highest in the third trimester. Contractions (p < 0.001), rupture of membranes (p = 0.005) and pregnancy-associated diseases (p = 0.003) were associated with higher HE4 levels. As much as 97.5% of HE4 measurements remained below the recommended cut-off for premenopausal women (70 pmol/l). CA 125 levels were not altered by pregnancy-associated conditions. Generally, CA 125 exhibited a wider serum level variability, exceeding the established cut-off of 35 U/ml in 16.4%.

          Conclusions HE4 serum levels are influenced by several pregnancy-related conditions leading to significantly higher levels in these cases. Despite differing medians according to trimester, the 95th percentile cut-offs and almost all maximum values during the entire course of pregnancy were below the established cut-off for premenopausal women. It was also superior to the performance of ROMA index. Therefore, HE4 can be used as a valuable negative predictive marker for the assessment of adnexal masses during pregnancy.

          Zusammenfassung

          Einleitung Die Änderungen von HE4 and CA 125, 2 etablierten Biomarkern für die Evaluierung von Adnextumoren in nicht schwangeren Frauen, wurden bislang kaum während der Schwangerschaft untersucht, vor allem nicht im Zusammenhang mit schwangerschaftsbedingten Erkrankungen. Ziel dieser Studie war es, den HE4- und CA-125-Serumspiegel im Verlauf der Schwangerschaft zu messen und die Auswirkungen von schwangerschaftsbedingten Erkrankungen, Wehentätigkeit und Blasensprung auf die HE4- und CA-125-Serumspiegel auszuwerten, um diese Parameter für die Evaluierung von Adnexbefunden während der Schwangerschaft einzusetzen.

          Patienten und Methoden Von 201 Frauen, die an der Medizinischen Universität Innsbruck, Österreich vorstellig waren, wurden Blutproben (n = 238) prospektiv während der Schwangerschaft sowie nach der Entbindung entnommen. Die Serumkonzentrationen von HE4 und CA 125 wurden ausgewertet. Der jeweilige ROMA-Index wurde anhand der prämenopausalen Formel kalkuliert.

          Ergebnisse Die höchsten Werte des HE4-Serumspiegels wurden im 3. Trimenon gemessen. Wehentätigkeit (p < 0,001), Blasensprung (p = 0,005) und schwangerschaftsbedingte Erkrankungen (p = 0,003) waren ebenfalls mit höheren HE4-Werte assoziiert. Fast 97,5% der gemessenen HE4-Werte blieben aber unter dem empfohlenen Cut-off-Wert für prämenopausale Frauen (70 pmol/l). Schwangerschaftsbedingte Erkrankungen hatten keine Auswirkung auf die Höhe der CA-125-Werte. Die Variabilität der Serumwerte war aber für CA-125-Werte größer, und bei 16,4% der Patientinnen wurde der etablierte Cut-off-Wert von 35 U/ml überschritten.

          Schlussfolgerungen Mehrere schwangerschaftsbedingte Erkrankungen wirkten sich auf die HE4-Serumwerte aus, und die Serumwerte waren bei diesen Patientinnen signifikant erhöht. Obwohl sich die Medianwerte je nach Trimenon unterschieden, blieben die Cut-off-Werte des 95. Perzentils sowie fast alle Maximalwerte während der gesamten Schwangerschaftsdauer unter den etablierten Cut-off-Werten für prämenopausale Frauen. Die Leistungsfähigkeit dieser Werte übertraf sogar die Aussagekraft des ROMA-Indexes. Damit stellen HE4-Werte einen nützlichen negativen prädiktiven Marker bei der Einschätzung von Adnexbefunden während der Schwangerschaft dar.

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          Most cited references28

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          A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass.

          Patients diagnosed with epithelial ovarian cancer (EOC) have improved outcomes when cared for at centers experienced in the management of EOC. The objective of this trial was to validate a predictive model to assess the risk for EOC in women with a pelvic mass. Women diagnosed with a pelvic mass and scheduled to have surgery were enrolled on a multicenter prospective study. Preoperative serum levels of HE4 and CA125 were measured. Separate logistic regression algorithms for premenopausal and postmenopausal women were utilized to categorize patients into low and high risk groups for EOC. Twelve sites enrolled 531 evaluable patients with 352 benign tumors, 129 EOC, 22 LMP tumors, 6 non EOC and 22 non ovarian cancers. The postmenopausal group contained 150 benign cases of which 112 were classified as low risk giving a specificity of 75.0% (95% CI 66.9-81.4), and 111 EOC and 6 LMP tumors of which 108 were classified as high risk giving a sensitivity of 92.3% (95% CI=85.9-96.4). The premenopausal group had 202 benign cases of which 151 were classified as low risk providing a specificity of 74.8% (95% CI=68.2-80.6), and 18 EOC and 16 LMP tumors of which 26 were classified as high risk, providing a sensitivity of 76.5% (95% CI=58.8-89.3). An algorithm utilizing HE4 and CA125 successfully classified patients into high and low risk groups with 93.8% of EOC correctly classified as high risk. This model can be used to effectively triage patients to centers of excellence.
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            HE4 a novel tumour marker for ovarian cancer: comparison with CA 125 and ROMA algorithm in patients with gynaecological diseases

            The aim of this study is to evaluate a new tumour marker, HE4, in comparison with CA 125 and the Risk of Ovarian Malignancy Algorithm (ROMA) in healthy women and in patients with benign and malignant gynaecological diseases. CA 125 and HE4 serum levels were determined in 66 healthy women, 285 patients with benign gynaecological diseases (68 endometriosis, 56 myomas, 137 ovarian cysts and 24 with other diseases), 33 patients with non-active gynaecological cancer and 143 with active gynaecological cancer (111 ovarian cancers). CA 125 and HE4 cut-offs were 35 U/mL and 150 pmol/L, respectively. ROMA algorithm cut-off was 13.1 and 27.7 for premenopausal or postmenopausal women, respectively. HE4, CA 125 and ROMA results were abnormal in 1.5%, 13.6% and 25.8% of healthy women and in 1.1%, 30.2% and 12.3% of patients with benign diseases, respectively. Among patients with cancer, HE4 (in contrast to CA 125) had significantly higher concentrations in ovarian cancer than in other malignancies (p < 0.001). Tumour marker sensitivity in ovarian cancer was 79.3% for HE4, 82.9% for CA 125 and 90.1% for ROMA. Both tumour markers, HE4 and CA 125 were related to tumour stage and histological type, with the lowest concentrations in mucinous tumours. A significantly higher area under the ROC curve was obtained with ROMA and HE4 than with CA 125 in the differential diagnosis of benign gynaecological diseases versus malignant ovarian cancer (0.952, 0.936 and 0.853, respectively). Data from our population indicate that ROMA algorithm might be further improved if it is used only in patients with normal HE4 and abnormal CA 125 serum levels (cancer risk for this profile is 44.4%). ROMA algorithm in HE4 positive had a similar sensitivity and only increases the specificity by 3.2% compared to HE4 alone.
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              Serum HE4 levels are less frequently elevated than CA125 in women with benign gynecologic disorders.

              The human epididymis protein 4 (HE4) is a novel biomarker for ovarian cancer. This study measured the HE4 and CA125 levels in women with benign gynecological disorders. Sera were obtained from women prior to surgery for a pelvic mass and HE4 and CA125 levels were determined. The proportions of patients with elevated biomarker levels were compared. There were 1042 women with benign disease. HE4 levels were less often elevated than CA125 (8% vs 29%, P < .001). A marked difference was observed in patients with endometriosis in which HE4 was elevated in 3% of patients and CA125 in 67% (P < .0001). Serous ovarian tumors were associated with elevated levels of HE4 in 8% of patients and CA125 in 20% (P = .0002); uterine fibroids in 8% vs 26% (P = .0083); dermoids in 1% vs 21% (P = .0004); and inflammatory disease in 10% vs 37% (P = .014). HE4 is elevated less frequently than CA125 in benign disease, particularly in premenopausal patients. Copyright © 2012 Mosby, Inc. All rights reserved.
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                Author and article information

                Journal
                Geburtshilfe Frauenheilkd
                Geburtshilfe Frauenheilkd
                10.1055/s-00000020
                Geburtshilfe und Frauenheilkunde
                Georg Thieme Verlag KG (Rüdigerstraße 14, 70469 Stuttgart, Germany )
                0016-5751
                1438-8804
                September 2021
                13 September 2021
                1 September 2021
                : 81
                : 9
                : 1047-1054
                Affiliations
                [1 ]Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria
                [2 ]Department of Gynecological Endocrinology and Reproductive Medicine, Medical University of Innsbruck, Innsbruck, Austria
                [3 ]Department of Gynecology and Obstetrics, Laboratory for Clinical Biochemistry, Medical University of Innsbruck, Innsbruck, Austria
                Author notes
                Correspondence Irene Mutz-Dehbalaie, MD Department of Obstetrics and Gynecology Medical University of Innsbruck Anichstrasse 356020 InnsbruckAustria irene.mutz-dehbalaie@ 123456i-med.ac.at
                Article
                14754296
                10.1055/a-1475-4296
                8437581
                fab6d8cb-3fc2-4ef8-bb2c-2e9f70cd634f
                The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ )

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.

                History
                : 11 December 2020
                : 05 April 2021
                Categories
                GebFra Science
                Original Article

                he4,ca 125,pregnancy,tumor marker,biomarker,adnexal mass,schwangerschaft,tumormarker,adnextumor

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