Clinical trial NCT05244668: Multicenter Validation of the Salivary miRNA Signature of Endometriosis
Official title: Multicenter Validation of the Salivary miRNA Signature of Endometriosis - The ENDOmiARN Salive Test Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Keywords: miRNA
MAP
machine learning algorithms
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
name: iGenSeq
First posted: 2022-02-17
Enrollment: 1140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: At least a 90% Sensitivity (True Positive Rate) of Endometriosis diagnotic confirmation using a miRNA signature
timeFrame: Through the end of study inclusions, an average of 1 year
measure: At least a 90% Specificity (True Negative Rate) of Endometriosis diagnotic confirmation using a miRNA signature
timeFrame: Through the end of study inclusions, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHU Québec
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital Hautepierre
state: Alsace
city: Caen
country: France
facility: CHU de Caen
state: Calvados
city: Bordeaux
country: France
facility: Clinique Tivoli
state: Gironde
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
state: Haute Garonne
city: Toulouse
country: France
facility: Clinique Pasteur
state: Haute-Garonne
city: Rennes
country: France
facility: Clinique La Sagesse
state: Ille Et Vilaine
city: Lyon
country: France
facility: Cabinet de Gynécologie Médicale
state: Rhône
city: Bois-Guillaume
country: France
facility: CHU Rouen
state: Seine-Maritime
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital BICETRE
state: Val De Marne
city: Maurepas
country: France
facility: Centre médical des Pyramides
state: Yvelines
city: Angers
country: France
facility: CHU Angers
city: Bastia
country: France
facility: CH Bastia
city: Lyon
country: France
facility: HCL
city: Paris
country: France
facility: Groupe Hospitalier Saint Josef
city: Paris
country: France
facility: Centre d'imagerie Manin Crimée
city: Paris
country: France
facility: CHU Tenons
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: