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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
| iGenSeq | UNKNOWN |
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ENDOmiARN Salive Test is a multicentre external validation study of a salivary signature of endometriosis carried out in France in Obstetrics and Reproductive Medicine departments, in order to evaluate its performance and discuss its use in clinical practice. The clinical application is to significantly reduce the time to diagnosis and improve the care pathway for endometriosis.
The study population is made up of women aged 18 to 43 years with formally diagnosed endometriosis or suspected endometriosis who are already receiving either medical (MAP) or surgical treatment as part of their routine care.
The patients concerned by the study are managed without any change in the care pathway, nor any change in the therapeutic indications, nor any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the HAS recommendations.
In this study, the management and follow-up of patients :
Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
Are not modified in comparison with the usual follow-up, except for the performance of :
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| Measure | Description | Time Frame |
|---|---|---|
| At least a 90% Sensitivity (True Positive Rate) of Endometriosis diagnotic confirmation using a miRNA signature | External validation of the salivary signature of endometriosis miRNAs | Through the end of study inclusions, an average of 1 year |
| At least a 90% Specificity (True Negative Rate) of Endometriosis diagnotic confirmation using a miRNA signature | External validation of the salivary signature of endometriosis miRNAs | Through the end of study inclusions, an average of 1 year |
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Inclusion Criteria:
Patient aged between 18 and 43 years,
Patient having dated and signed the consent form,
Patient affiliated to the French health system,
Patient with pelvic MRI and/or pelvic ultrasound,
Patient from one of the 3 study populations:
Exclusion Criteria:
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The study population is made up of women aged 18 to 43 years with a formal diagnosis of endometriosis or suspected endometriosis.
The patients concerned by the study are already receiving either medical (MAP) or surgical care in a department of Obstetrics and Reproductive Medicine.
All these patients already benefit from validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical or fertility RCP).
The patients concerned by the study are managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Québec | Québec | Canada | ||||
| CHU Strasbourg - Hôpital Hautepierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41147827 | Derived | Bendifallah S, Roman H, Suisse S, Spiers A, Petit E, Delbos L, Dabi Y, Touboul C, Dennis T, Merlot B, Sauvanet E, Fauvet R, Jamard E, Clotilde H, Morgane P, Fedida B, Nyangoh K, Lavoue V, Roger CM, Lucas N, Darnaud T, Boudy AS, Genre L, Leguevaque P, Akldios C, Benjoar M, Chantalat E, Tanguy Le Gac Y, Poilblanc M, Rousset P, Fernandez H, Golfier F, Descamps P. Validation of a Saliva Micro-RNA Signature for Endometriosis. NEJM Evid. 2025 Nov;4(11):EVIDoa2400195. doi: 10.1056/EVIDoa2400195. Epub 2025 Oct 28. | |
| 38320163 |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Saliva
| Strasbourg |
| Alsace |
| 67200 |
| France |
| CHU de Caen | Caen | Calvados | 14000 | France |
| Clinique Tivoli | Bordeaux | Gironde | 33000 | France |
| CHU Toulouse - Hôpital Rangueil | Toulouse | Haute Garonne | 31059 | France |
| Clinique Pasteur | Toulouse | Haute-Garonne | 31300 | France |
| Clinique La Sagesse | Rennes | Ille Et Vilaine | 35000 | France |
| Cabinet de Gynécologie Médicale | Lyon | Rhône | 69002 | France |
| CHU Rouen | Bois-Guillaume | Seine-Maritime | 76230 | France |
| Hôpital BICETRE | Le Kremlin-Bicêtre | Val De Marne | 94275 | France |
| Centre médical des Pyramides | Maurepas | Yvelines | 78310 | France |
| CHU Angers | Angers | 49933 | France |
| CH Bastia | Bastia | 20600 | France |
| HCL | Lyon | 69000 | France |
| Groupe Hospitalier Saint Josef | Paris | 75014 | France |
| Centre d'imagerie Manin Crimée | Paris | 75019 | France |
| CHU Tenons | Paris | 75020 | France |
| CHU Rennes | Rennes | 35000 | France |
| Derived |
| Bendifallah S, Dabi Y, Suisse S, Delbos L, Spiers A, Poilblanc M, Golfier F, Jornea L, Bouteiller D, Fernandez H, Madar A, Petit E, Perotte F, Fauvet R, Benjoar M, Akladios C, Lavoue V, Darnaud T, Merlot B, Roman H, Touboul C, Descamps P. Validation of a Salivary miRNA Signature of Endometriosis - Interim Data. NEJM Evid. 2023 Jul;2(7):EVIDoa2200282. doi: 10.1056/EVIDoa2200282. Epub 2023 Jun 9. |
| D000091662 | Genital Diseases |