Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
Study NCT ID:
NCT05244668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2022-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Validation of the Salivary miRNA Signature of Endometriosis
Sponsor:
ZIWIG
Organization:
Study Overview
Official Title:
Multicenter Validation of the Salivary miRNA Signature of Endometriosis - The ENDOmiARN Salive Test Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: