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Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis

Recruitingn/aAges 14 Years - 49 YearsFemaleDiamens FlexCo
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In plain words

What the trial is, and whether it could suit you

Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients. This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples. Study Objective: The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls. Study Design: This is

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: * Women aged 14 to 49 * Menstruating * Endometriosis group * Histologically confirmed endometriosis * Imaging-verified endometriosis * Laparoscopy-negative group: \- Laparoscopy with no evidence of endometriosis * Imaging-negative group: * Healthy women (no symptoms of endometriosis) * Imaging shows no evidence of endometriosis Exclusion criteria: * Amenorrhea * Pregnancy * Oncological diseases * Use of GnRH agonists or antagonists
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What it tests

  • Not listed
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Where

8 sites
Gynlounge
Linz, Austria
Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklinikum
Linz, Austria
Gynäkologie und Geburtshilfe am Landesklinikum Melk
Melk, Austria
Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH
Mödling, Austria
Wahlarztordination Puschacher
Pöggstall, Austria
Krankenhaus der Barmherzigen Brüder Wien
Vienna, Austria
Frauenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig
Regensburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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