Status:
ACTIVE_NOT_RECRUITING
Multicenter Validation of the Salivary miRNA Signature of Endometriosis
Lead Sponsor:
ZIWIG
Collaborating Sponsors:
Monitoring Force Group
iGenSeq
Conditions:
Endometriosis
Eligibility:
FEMALE
18-43 years
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT05244668
Start Date
December 15 2021
End Date
April 1 2024
Last Update
March 20 2024
Active Locations (18)
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1
CHU Québec
Québec, Canada
2
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Alsace, France, 67200
3
CHU de Caen
Caen, Calvados, France, 14000
4
Clinique Tivoli
Bordeaux, Gironde, France, 33000