Endosearch: The International Clinical Trial to Test a Cluster of Biomarkers to Diagnose Endometriosis

Abstract

Study Objective The aim of our study is to test a combination of biological markers differentially expressed in samples from women with or without endometriosis. Methods Design ENDOSEARCH is a prospective multicentric international clinical trial registered with Clinical Trial.gov. Setting 20 renowned specialized centers in Europe, USA, Canada, and the Indian Ocean, granted by the European Union aiming to validate a cluster of biomarkers. Patients or Participants 1000 patients. The Patient Group includes women between 18 and 45 with suspected endometriosis undergoing laparoscopy. Patients with predominant adenomyosis and/or fibroids diagnosed by imaging, chronic, malignant, infectious, metabolic or endocrine diseases are excluded. The Control Group includes patients of same age group without any endometriosis-related clinical sign, with planned laparoscopic surgery for other indications. Samples of endometriosis lesions and endometrial biopsies for both groups are sent to a unique center (Endodiag, Paris, France) to be tested with the cluster of biomarkers. Interventions Laparoscopy for endometriosis or benign conditions (Control group). Measurements and Main Results 40% of the patients recruited in the Endometriosis group have already had at least one and up to 4 previous laparoscopies for endometriosis. Almost 50% of the patients had an AFS score of III or IV. 14% of the patients suspected of endometriosis had negative pathology while 2% of the patients in the control group had severe endometriosis at laparoscopy and were excluded. Conclusion We present the first large prospective multicentric international clinical trial aiming to test a cluster of biomarkers to diagnose endometriosis by recruiting over 1000 patients all around Europe, the US and Canada. Even in major referral centers almost 14% of the pre-op diagnosis were negative at pathology while 2% of the control group had severe endometriosis. Those preliminary results with others show the necessity of development of accurate biological tests to diagnose endometriosis and avoid unnecessary laparoscopies.