Multicenter Validation of the Salivary miRNA Signature of Endometriosis

Endometriosis Clinical Trial

Official title:

Multicenter Validation of the Salivary miRNA Signature of Endometriosis - The ENDOmiARN Salive Test Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05244668
• Other study ID #: FR-21-001
• Status: Active, not recruiting
• Start date: December 15, 2021
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: ZIWIG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1140
• Est. completion date: April 2024
• Est. primary completion date: January 6, 2023
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Canada	CHU Québec	Québec
France	CHU Angers	Angers
France	CH Bastia	Bastia
France	CHU Rouen	Bois-Guillaume	Seine-Maritime
France	Clinique Tivoli	Bordeaux	Gironde
France	CHU de Caen	Caen	Calvados
France	Hôpital BICETRE	Le Kremlin-Bicêtre	Val De Marne
France	Cabinet de Gynécologie Médicale	Lyon	Rhône
France	HCL	Lyon
France	Centre médical des Pyramides	Maurepas	Yvelines
France	Centre d'imagerie Manin Crimée	Paris
France	CHU Tenons	Paris
France	Groupe Hospitalier Saint Josef	Paris
France	CHU Rennes	Rennes
France	Clinique La Sagesse	Rennes	Ille Et Vilaine
France	CHU Strasbourg - Hôpital Hautepierre	Strasbourg	Alsace
France	CHU Toulouse - Hôpital Rangueil	Toulouse	Haute Garonne
France	Clinique Pasteur	Toulouse	Haute-Garonne

Sponsors (3)

Lead Sponsor	Collaborator
ZIWIG	iGenSeq, Monitoring Force Group

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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