Multicenter Validation of the Salivary miRNA Signature of Endometriosis

NCT05244668 | Completed

• 1 other identifier: FR-21-001
• Study Type: observational
• Target: 1,140
• Locations: 2 countries
• Sites: 18

Brief Summary

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 :
• Collection of saliva
• Electronic collection of the answers to the questionnaires completed by the patient

Conditions

Endometriosis

Keywords

miRNA; MAP; machine learning algorithms

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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:
• Patient with a formal endometriosis diagnosed by clinical examination and imaging AND an indication for specialised endometriosis follow-up or medically assisted procreation (MAP) or surgery validated by RCP (in routine care);
• Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical and radiological data AND a surgical indication validated by RCP (in routine care);
• Patient with a gynaecological indication for surgery of the small pelvis by laparoscopy or laparoscopy validated in RCP (in routine care) AND symptoms suggestive of endometriosis (dysmenorrhoea, ....)(1).

You may not qualify if:

• Patient with recurrence of deep endometriosis (excluding endometrioma),
• Patient with endometriosis of the torus and/or utero-sacral ligaments without indication for surgery,
• Patient with parietal endometriosis alone without indication for surgery,
• Patient with adenomyosis alone on imaging without indication for surgery,
• Patient with gynaecological infection requiring surgical management,
• Pregnant patient,
• Patient infected with the human immunodeficiency virus (HIV),
• Patient with significant difficulties in reading or writing the French language,
• Patient with a personal history of cancer,
• Patient unable to comply with study and/or follow-up procedures,
• Patient who has objected to the collection of her data.
• Patient participating in another clinical research study.

Sponsors & Collaborators

• ZIWIG: lead
• Monitoring Force Group: collaborator
• iGenSeq: collaborator

Study Sites (18)

CHU Québec

Québec, Canada

Location

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Alsace, 67200, France

Location

CHU de Caen

Caen, Calvados, 14000, France

Location

Clinique Tivoli

Bordeaux, Gironde, 33000, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne, 31059, France

Location

Clinique Pasteur

Toulouse, Haute-Garonne, 31300, France

Location

Clinique La Sagesse

Rennes, Ille Et Vilaine, 35000, France

Location

Cabinet de Gynécologie Médicale

Lyon, Rhône, 69002, France

Location

CHU Rouen

Bois-Guillaume, Seine-Maritime, 76230, France

Location

Hôpital BICETRE

Le Kremlin-Bicêtre, Val De Marne, 94275, France

Location

Centre médical des Pyramides

Maurepas, Yvelines, 78310, France

Location

CHU Angers

Angers, 49933, France

Location

CH Bastia

Bastia, 20600, France

Location

HCL

Lyon, 69000, France

Location

Groupe Hospitalier Saint Josef

Paris, 75014, France

Location

Centre d'imagerie Manin Crimée

Paris, 75019, France

Location

CHU Tenons

Paris, 75020, France

Location

CHU Rennes

Rennes, 35000, France

Location

Related Publications (2)

• 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.

  PMID: 41147827 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.

  PMID: 38320163 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 17, 2022
• Study Start: December 15, 2021
• Primary Completion: January 6, 2023
• Study Completion: February 28, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (17); CA (1)