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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05244668
Other study ID # FR-21-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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