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NCT05244668Completed

Multicenter Validation of the Salivary miRNA Signature of Endometriosis

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
1140 (actual)
First submitted
19 Jan 2022
Start date
15 Dec 2021
Primary completion date
6 Jan 2023
Lead sponsor
ZIWIG
NCT number
NCT05244668

What you commit to

  • Study type: Observational
  • Participants enrolled: 1140
  • From 15 Dec 2021 to the primary completion date, 6 Jan 2023
  • 18 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Other illness

  • Patient with gynaecological infection requiring surgical management,
  • Patient infected with the human immunodeficiency virus (HIV),
  • Patient with a personal history of cancer,

Other

  • Patient with recurrence of deep endometriosis (excluding endometrioma),
  • Pregnant patient,
  • Patient with significant difficulties in reading or writing the French language,
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 43 years · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Québec
Coordinator of this site? Confirm its status		QuébecCanadaUnknown status
CHU Angers
Coordinator of this site? Confirm its status		AngersFranceUnknown status
CH Bastia
Coordinator of this site? Confirm its status		BastiaFranceUnknown status
CHU Rouen
Coordinator of this site? Confirm its status		Bois-GuillaumeFranceUnknown status
Clinique Tivoli
Coordinator of this site? Confirm its status		BordeauxFranceUnknown status
CHU de CAEN
Coordinator of this site? Confirm its status		CaenFranceUnknown status
Hopital Bicetre
Coordinator of this site? Confirm its status		Le Kremlin-BicêtreFranceUnknown status
HCL
Coordinator of this site? Confirm its status		LyonFranceUnknown status
Cabinet de Gynécologie Médicale
Coordinator of this site? Confirm its status		LyonFranceUnknown status
Centre médical des Pyramides
Coordinator of this site? Confirm its status		MaurepasFranceUnknown status
Groupe Hospitalier Saint Josef
Coordinator of this site? Confirm its status		ParisFranceUnknown status
Centre d'imagerie Manin Crimée
Coordinator of this site? Confirm its status		ParisFranceUnknown status
CHU Tenons
Coordinator of this site? Confirm its status		ParisFranceUnknown status
CHU Rennes
Coordinator of this site? Confirm its status		RennesFranceUnknown status
Clinique La sagesse
Coordinator of this site? Confirm its status		RennesFranceUnknown status
CHU Strasbourg - Hôpital Hautepierre
Coordinator of this site? Confirm its status		StrasbourgFranceUnknown status
Clinique Pasteur
Coordinator of this site? Confirm its status		ToulouseFranceUnknown status
Chu Toulouse Hopital Rangueil
Coordinator of this site? Confirm its status		ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.