Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study
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...
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| Veröffentlicht in: | International journal of gynecology and obstetrics 2024-01, Vol.164 (1), p.305-314 |
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| creator | Burghaus, Stefanie Drazic, Predrag Wölfler, Monika Mechsner, Sylvia Zeppernick, Magdalena Meinhold‐Heerlein, Ivo Mueller, Michael D. Rothmund, Ralf Vigano, Paola Becker, Christian M. Zondervan, Krina T. Beckmann, Matthias W. Fasching, Peter A. Berner‐Gatz, Sibylle Grünewald, Felix S. Hund, Martin Kastner, Peter Klammer, Martin Laubender, Ruediger P. Wegmeyer, Heike Wienhues‐Thelen, Ursula‐Henrike Renner, Stefan P. |
| description | 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 |
| doi_str_mv | 10.1002/ijgo.15062 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2858409948</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2858409948</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3652-9580dd77a3d7600104aae6497792690063b130deadba191eb6e198b5434acd433</originalsourceid><addsrcrecordid>eNp9kbFOwzAQhi0EoqWw8ADII0JKsePEjtlQBaWoqAvMkRNfwSWJS5wUdeMN4Bl5EhzaMjKdrPv0ne9-hE4pGVJCwkuzeLZDGhMe7qE-TYQMWCTkPur7JglEKMMeOnJuQQihgtJD1GOCs5gnrI8-H9qiMTlUDdQYVqpoVWNshe0cZ4W1-vvjK1MONM6MLVX9CrXDc1vj5gWwhgbyHQ2VtiU0tbHOOKwqjZWGypbr7n2Fr_Gytm7Z8SvAla282HRDV360V6gCu6bV62N0MFeFg5NtHaCn25vH0V0wnY0no-tpkDMeh4GME6K1EIppwf1aJFIKeCSFkCGXhHCWUUY0KJ0pKilkHKhMsjhikcp1xNgAnW-8_ltvLbgmLY3LoShUBbZ1aZjESUSkjBKPXmzQ3G_gapiny9r4W6xTStIugLQLIP0NwMNnW2-blaD_0N3FPUA3wLspYP2PKp3cj2cb6Q-rfpXV</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2858409948</pqid></control><display><type>article</type><title>Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Burghaus, Stefanie ; Drazic, Predrag ; Wölfler, Monika ; Mechsner, Sylvia ; Zeppernick, Magdalena ; Meinhold‐Heerlein, Ivo ; Mueller, Michael D. ; Rothmund, Ralf ; Vigano, Paola ; Becker, Christian M. ; Zondervan, Krina T. ; Beckmann, Matthias W. ; Fasching, Peter A. ; Berner‐Gatz, Sibylle ; Grünewald, Felix S. ; Hund, Martin ; Kastner, Peter ; Klammer, Martin ; Laubender, Ruediger P. ; Wegmeyer, Heike ; Wienhues‐Thelen, Ursula‐Henrike ; Renner, Stefan P.</creator><creatorcontrib>Burghaus, Stefanie ; Drazic, Predrag ; Wölfler, Monika ; Mechsner, Sylvia ; Zeppernick, Magdalena ; Meinhold‐Heerlein, Ivo ; Mueller, Michael D. ; Rothmund, Ralf ; Vigano, Paola ; Becker, Christian M. ; Zondervan, Krina T. ; Beckmann, Matthias W. ; Fasching, Peter A. ; Berner‐Gatz, Sibylle ; Grünewald, Felix S. ; Hund, Martin ; Kastner, Peter ; Klammer, Martin ; Laubender, Ruediger P. ; Wegmeyer, Heike ; Wienhues‐Thelen, Ursula‐Henrike ; Renner, Stefan P.</creatorcontrib><description>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 < 0.001) and increased (P < 0.001) with disease stage. In “all endometriosis cases” versus “pathology‐free symptomatic controls”, S100‐A12 performed best (AUC 0.692, 95% CI 0.614–0.769, q = 0.001) followed by CA‐125 (AUC 0.649, 95% CI 0.569–0.729, q = 0.021). In “adenomyosis only cases” versus “symptomatic controls” or “pathology‐free symptomatic controls”, respectively, the top‐performing biomarkers were sFRP‐4 (AUC 0.615, 95% CI 0.551–0.678, q = 0.045) and S100‐A12 (AUC 0.701, 95% CI 0.611–0.792, q = 0.004).
Conclusion
This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.
Synopsis
None of the biomarkers or biomarker combinations studied could diagnose or rule out endometriosis/adenomyosis with a high level of certainty.</description><identifier>ISSN: 0020-7292</identifier><identifier>EISSN: 1879-3479</identifier><identifier>DOI: 10.1002/ijgo.15062</identifier><identifier>PMID: 37635683</identifier><language>eng</language><publisher>United States</publisher><subject>adenomyosis ; Adenomyosis - diagnosis ; Adenomyosis - pathology ; Biomarkers ; blood‐based biomarkers ; CA‐125 ; diagnosis ; endometriosis ; Endometriosis - diagnosis ; Female ; Humans ; Prospective Studies ; ROC Curve ; S100‐A12 ; sFRP‐4</subject><ispartof>International journal of gynecology and obstetrics, 2024-01, Vol.164 (1), p.305-314</ispartof><rights>2023 The Authors. published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.</rights><rights>2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3652-9580dd77a3d7600104aae6497792690063b130deadba191eb6e198b5434acd433</citedby><cites>FETCH-LOGICAL-c3652-9580dd77a3d7600104aae6497792690063b130deadba191eb6e198b5434acd433</cites><orcidid>0000-0001-8640-6033</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fijgo.15062$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fijgo.15062$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37635683$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Burghaus, Stefanie</creatorcontrib><creatorcontrib>Drazic, Predrag</creatorcontrib><creatorcontrib>Wölfler, Monika</creatorcontrib><creatorcontrib>Mechsner, Sylvia</creatorcontrib><creatorcontrib>Zeppernick, Magdalena</creatorcontrib><creatorcontrib>Meinhold‐Heerlein, Ivo</creatorcontrib><creatorcontrib>Mueller, Michael D.</creatorcontrib><creatorcontrib>Rothmund, Ralf</creatorcontrib><creatorcontrib>Vigano, Paola</creatorcontrib><creatorcontrib>Becker, Christian M.</creatorcontrib><creatorcontrib>Zondervan, Krina T.</creatorcontrib><creatorcontrib>Beckmann, Matthias W.</creatorcontrib><creatorcontrib>Fasching, Peter A.</creatorcontrib><creatorcontrib>Berner‐Gatz, Sibylle</creatorcontrib><creatorcontrib>Grünewald, Felix S.</creatorcontrib><creatorcontrib>Hund, Martin</creatorcontrib><creatorcontrib>Kastner, Peter</creatorcontrib><creatorcontrib>Klammer, Martin</creatorcontrib><creatorcontrib>Laubender, Ruediger P.</creatorcontrib><creatorcontrib>Wegmeyer, Heike</creatorcontrib><creatorcontrib>Wienhues‐Thelen, Ursula‐Henrike</creatorcontrib><creatorcontrib>Renner, Stefan P.</creatorcontrib><title>Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study</title><title>International journal of gynecology and obstetrics</title><addtitle>Int J Gynaecol Obstet</addtitle><description>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 < 0.001) and increased (P < 0.001) with disease stage. In “all endometriosis cases” versus “pathology‐free symptomatic controls”, S100‐A12 performed best (AUC 0.692, 95% CI 0.614–0.769, q = 0.001) followed by CA‐125 (AUC 0.649, 95% CI 0.569–0.729, q = 0.021). In “adenomyosis only cases” versus “symptomatic controls” or “pathology‐free symptomatic controls”, respectively, the top‐performing biomarkers were sFRP‐4 (AUC 0.615, 95% CI 0.551–0.678, q = 0.045) and S100‐A12 (AUC 0.701, 95% CI 0.611–0.792, q = 0.004).
Conclusion
This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.
Synopsis
None of the biomarkers or biomarker combinations studied could diagnose or rule out endometriosis/adenomyosis with a high level of certainty.</description><subject>adenomyosis</subject><subject>Adenomyosis - diagnosis</subject><subject>Adenomyosis - pathology</subject><subject>Biomarkers</subject><subject>blood‐based biomarkers</subject><subject>CA‐125</subject><subject>diagnosis</subject><subject>endometriosis</subject><subject>Endometriosis - diagnosis</subject><subject>Female</subject><subject>Humans</subject><subject>Prospective Studies</subject><subject>ROC Curve</subject><subject>S100‐A12</subject><subject>sFRP‐4</subject><issn>0020-7292</issn><issn>1879-3479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp9kbFOwzAQhi0EoqWw8ADII0JKsePEjtlQBaWoqAvMkRNfwSWJS5wUdeMN4Bl5EhzaMjKdrPv0ne9-hE4pGVJCwkuzeLZDGhMe7qE-TYQMWCTkPur7JglEKMMeOnJuQQihgtJD1GOCs5gnrI8-H9qiMTlUDdQYVqpoVWNshe0cZ4W1-vvjK1MONM6MLVX9CrXDc1vj5gWwhgbyHQ2VtiU0tbHOOKwqjZWGypbr7n2Fr_Gytm7Z8SvAla282HRDV360V6gCu6bV62N0MFeFg5NtHaCn25vH0V0wnY0no-tpkDMeh4GME6K1EIppwf1aJFIKeCSFkCGXhHCWUUY0KJ0pKilkHKhMsjhikcp1xNgAnW-8_ltvLbgmLY3LoShUBbZ1aZjESUSkjBKPXmzQ3G_gapiny9r4W6xTStIugLQLIP0NwMNnW2-blaD_0N3FPUA3wLspYP2PKp3cj2cb6Q-rfpXV</recordid><startdate>202401</startdate><enddate>202401</enddate><creator>Burghaus, Stefanie</creator><creator>Drazic, Predrag</creator><creator>Wölfler, Monika</creator><creator>Mechsner, Sylvia</creator><creator>Zeppernick, Magdalena</creator><creator>Meinhold‐Heerlein, Ivo</creator><creator>Mueller, Michael D.</creator><creator>Rothmund, Ralf</creator><creator>Vigano, Paola</creator><creator>Becker, Christian M.</creator><creator>Zondervan, Krina T.</creator><creator>Beckmann, Matthias W.</creator><creator>Fasching, Peter A.</creator><creator>Berner‐Gatz, Sibylle</creator><creator>Grünewald, Felix S.</creator><creator>Hund, Martin</creator><creator>Kastner, Peter</creator><creator>Klammer, Martin</creator><creator>Laubender, Ruediger P.</creator><creator>Wegmeyer, Heike</creator><creator>Wienhues‐Thelen, Ursula‐Henrike</creator><creator>Renner, Stefan P.</creator><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8640-6033</orcidid></search><sort><creationdate>202401</creationdate><title>Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study</title><author>Burghaus, Stefanie ; Drazic, Predrag ; Wölfler, Monika ; Mechsner, Sylvia ; Zeppernick, Magdalena ; Meinhold‐Heerlein, Ivo ; Mueller, Michael D. ; Rothmund, Ralf ; Vigano, Paola ; Becker, Christian M. ; Zondervan, Krina T. ; Beckmann, Matthias W. ; Fasching, Peter A. ; Berner‐Gatz, Sibylle ; Grünewald, Felix S. ; Hund, Martin ; Kastner, Peter ; Klammer, Martin ; Laubender, Ruediger P. ; Wegmeyer, Heike ; Wienhues‐Thelen, Ursula‐Henrike ; Renner, Stefan P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3652-9580dd77a3d7600104aae6497792690063b130deadba191eb6e198b5434acd433</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>adenomyosis</topic><topic>Adenomyosis - diagnosis</topic><topic>Adenomyosis - pathology</topic><topic>Biomarkers</topic><topic>blood‐based biomarkers</topic><topic>CA‐125</topic><topic>diagnosis</topic><topic>endometriosis</topic><topic>Endometriosis - diagnosis</topic><topic>Female</topic><topic>Humans</topic><topic>Prospective Studies</topic><topic>ROC Curve</topic><topic>S100‐A12</topic><topic>sFRP‐4</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Burghaus, Stefanie</creatorcontrib><creatorcontrib>Drazic, Predrag</creatorcontrib><creatorcontrib>Wölfler, Monika</creatorcontrib><creatorcontrib>Mechsner, Sylvia</creatorcontrib><creatorcontrib>Zeppernick, Magdalena</creatorcontrib><creatorcontrib>Meinhold‐Heerlein, Ivo</creatorcontrib><creatorcontrib>Mueller, Michael D.</creatorcontrib><creatorcontrib>Rothmund, Ralf</creatorcontrib><creatorcontrib>Vigano, Paola</creatorcontrib><creatorcontrib>Becker, Christian M.</creatorcontrib><creatorcontrib>Zondervan, Krina T.</creatorcontrib><creatorcontrib>Beckmann, Matthias W.</creatorcontrib><creatorcontrib>Fasching, Peter A.</creatorcontrib><creatorcontrib>Berner‐Gatz, Sibylle</creatorcontrib><creatorcontrib>Grünewald, Felix S.</creatorcontrib><creatorcontrib>Hund, Martin</creatorcontrib><creatorcontrib>Kastner, Peter</creatorcontrib><creatorcontrib>Klammer, Martin</creatorcontrib><creatorcontrib>Laubender, Ruediger P.</creatorcontrib><creatorcontrib>Wegmeyer, Heike</creatorcontrib><creatorcontrib>Wienhues‐Thelen, Ursula‐Henrike</creatorcontrib><creatorcontrib>Renner, Stefan P.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of gynecology and obstetrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Burghaus, Stefanie</au><au>Drazic, Predrag</au><au>Wölfler, Monika</au><au>Mechsner, Sylvia</au><au>Zeppernick, Magdalena</au><au>Meinhold‐Heerlein, Ivo</au><au>Mueller, Michael D.</au><au>Rothmund, Ralf</au><au>Vigano, Paola</au><au>Becker, Christian M.</au><au>Zondervan, Krina T.</au><au>Beckmann, Matthias W.</au><au>Fasching, Peter A.</au><au>Berner‐Gatz, Sibylle</au><au>Grünewald, Felix S.</au><au>Hund, Martin</au><au>Kastner, Peter</au><au>Klammer, Martin</au><au>Laubender, Ruediger P.</au><au>Wegmeyer, Heike</au><au>Wienhues‐Thelen, Ursula‐Henrike</au><au>Renner, Stefan P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study</atitle><jtitle>International journal of gynecology and obstetrics</jtitle><addtitle>Int J Gynaecol Obstet</addtitle><date>2024-01</date><risdate>2024</risdate><volume>164</volume><issue>1</issue><spage>305</spage><epage>314</epage><pages>305-314</pages><issn>0020-7292</issn><eissn>1879-3479</eissn><abstract>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 < 0.001) and increased (P < 0.001) with disease stage. In “all endometriosis cases” versus “pathology‐free symptomatic controls”, S100‐A12 performed best (AUC 0.692, 95% CI 0.614–0.769, q = 0.001) followed by CA‐125 (AUC 0.649, 95% CI 0.569–0.729, q = 0.021). In “adenomyosis only cases” versus “symptomatic controls” or “pathology‐free symptomatic controls”, respectively, the top‐performing biomarkers were sFRP‐4 (AUC 0.615, 95% CI 0.551–0.678, q = 0.045) and S100‐A12 (AUC 0.701, 95% CI 0.611–0.792, q = 0.004).
Conclusion
This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.
Synopsis
None of the biomarkers or biomarker combinations studied could diagnose or rule out endometriosis/adenomyosis with a high level of certainty.</abstract><cop>United States</cop><pmid>37635683</pmid><doi>10.1002/ijgo.15062</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8640-6033</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0020-7292 |
| ispartof | International journal of gynecology and obstetrics, 2024-01, Vol.164 (1), p.305-314 |
| issn | 0020-7292 1879-3479 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2858409948 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | adenomyosis Adenomyosis - diagnosis Adenomyosis - pathology Biomarkers blood‐based biomarkers CA‐125 diagnosis endometriosis Endometriosis - diagnosis Female Humans Prospective Studies ROC Curve S100‐A12 sFRP‐4 |
| title | Multicenter evaluation of blood‐based biomarkers for the detection of endometriosis and adenomyosis: A prospective non‐interventional study |
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