Multicenter Validation of the Salivary miRNA Signature of Endometriosis

NCT ID: NCT05244668

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2024-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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:

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monitoring Force Group

INDUSTRY

Sponsor Role: collaborator

iGenSeq

UNKNOWN

Sponsor Role: collaborator

ZIWIG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Québec

Québec, , Canada

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Alsace, France

CHU de Caen

Caen, Calvados, France

Clinique Tivoli

Bordeaux, Gironde, France

CHU Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne, France

Clinique Pasteur

Toulouse, Haute-Garonne, France

Clinique La Sagesse

Rennes, Ille Et Vilaine, France

Cabinet de Gynécologie Médicale

Lyon, Rhône, France

CHU Rouen

Bois-Guillaume, Seine-Maritime, France

Hôpital BICETRE

Le Kremlin-Bicêtre, Val De Marne, France

Centre médical des Pyramides

Maurepas, Yvelines, France

CHU Angers

Angers, , France

CH Bastia

Bastia, , France

HCL

Lyon, , France

Groupe Hospitalier Saint Josef

Paris, , France

Centre d'imagerie Manin Crimée

Paris, , France

CHU Tenons

Paris, , France

CHU Rennes

Rennes, , France

Countries

Canada; France

References

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.

Reference Type: DERIVED

PMID: 41147827 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38320163 (View on PubMed)

Other Identifiers

FR-21-001

Identifier Type: -

Identifier Source: org_study_id