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EndometriosisNCT05244668

Multicenter Validation of the Salivary miRNA Signature of Endometriosis

An observational study of Endometriosis, run by ZIWIG at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 43 years, women only
Conditions the study is for
Endometriosis
How many people
1,140 participants
Where
18 sitesin 2 countries
Study dates
15 Dec 2021to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 43 years
  • Women only
  • Adult

Study population: The study population is made up of women aged 18 to 43 years with a formal diagnosis of endometriosis or suspected endometriosis. The patients concerned by the study are already receiving either medical (MAP) or surgical care in a department of Obstetrics and Reproductive Medicine. All these patients already benefit from validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical or fertility RCP). The patients concerned by the study are managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.

Who may be able to join

  • 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).

Who cannot join

  • 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,
Show all 12Show fewer
  • 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.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

France17 sites

  • CHU Angers

    Angers, 49933

  • CH Bastia

    Bastia, 20600

  • CHU Rouen

    Bois-Guillaume, Seine-Maritime, 76230

  • Clinique Tivoli

    Bordeaux, Gironde, 33000

  • CHU de Caen

    Caen, Calvados, 14000

  • Hôpital BICETRE

    Le Kremlin-Bicêtre, Val De Marne, 94275

  • Cabinet de Gynécologie Médicale

    Lyon, Rhône, 69002

  • HCL

    Lyon, 69000

  • Centre médical des Pyramides

    Maurepas, Yvelines, 78310

  • Groupe Hospitalier Saint Josef

    Paris, 75014

  • Centre d'imagerie Manin Crimée

    Paris, 75019

  • CHU Tenons

    Paris, 75020

  • Clinique La Sagesse

    Rennes, Ille Et Vilaine, 35000

  • CHU Rennes

    Rennes, 35000

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Alsace, 67200

  • CHU Toulouse - Hôpital Rangueil

    Toulouse, Haute Garonne, 31059

  • Clinique Pasteur

    Toulouse, Haute-Garonne, 31300

Other trials in France

Canada1 site

  • CHU Québec

    Québec

Other trials in Canada

About this study

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

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.

Read more

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
Conditions
Endometriosis
Keywords
miRNA, MAP, machine learning algorithms
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through the end of study inclusions, an average of 1 year

  2. 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

    Measured: Through the end of study inclusions, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start15 Dec 2021
  3. Primary completion6 Jan 2023
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05244668
Sponsor's protocol ID
FR-21-001
Status last verified
Mar 2026
First submitted
19 Jan 2022
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bendifallah S, Roman H, Suisse S, Spiers A, Petit E, Delbos L, Dabi Y, Touboul C, Dennis T, Merlot B, Sauvanet E, Fauvet R, Jamard E, Clotilde H, Morgane P, Fedida B, Nyangoh K, Lavoue V, Roger CM, Lucas N, Darnaud T, Boudy AS, Genre L, Leguevaque P, Akldios C, Benjoar M, Chantalat E, Tanguy Le Gac Y, Poilblanc M, Rousset P, Fernandez H, Golfier F, Descamps P. Validation of a Saliva Micro-RNA Signature for Endometriosis. NEJM Evid. 2025 Nov;4(11):EVIDoa2400195. doi: 10.1056/EVIDoa2400195. Epub 2025 Oct 28.

    PubMed 41147827

  • Bendifallah S, Dabi Y, Suisse S, Delbos L, Spiers A, Poilblanc M, Golfier F, Jornea L, Bouteiller D, Fernandez H, Madar A, Petit E, Perotte F, Fauvet R, Benjoar M, Akladios C, Lavoue V, Darnaud T, Merlot B, Roman H, Touboul C, Descamps P. Validation of a Salivary miRNA Signature of Endometriosis - Interim Data. NEJM Evid. 2023 Jul;2(7):EVIDoa2200282. doi: 10.1056/EVIDoa2200282. Epub 2023 Jun 9.

    PubMed 38320163

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by ZIWIG at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

At least a 90% Sensitivity (True Positive Rate) of Endometriosis diagnotic confirmation using a miRNA signature (time frame: Through the end of study inclusions, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05244668, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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