Clinical trial NCT05928442: Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent
Official title: Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent - The ADOmiARN Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: miRNA
RNA
Machine learning algorithms
Adolescents
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
name: iGenSeq
First posted: 2023-07-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population made up of 3 differents adolescents populations:

* "Endometriosis" patients: diagnosis confirmed by imaging; endometriosis formally diagnosed on clinical or imaging examination (ovarian endometriosis and/or severe deep endometriosis with vaginal, lateral or colorectal involvement)
* "Discordants" patients: surgical confirmation; suspected endometriosis with discordant clinical and radiological data requiring surgical care (exploratory coelioscopy) for diagnosis in routine care, based on national recommendations and after validation by in RCP
* "Sugery" patients: Surgical procedure motivated by a reason other than endometriosis: adolescents with another pelvic pathology requiring a planned surgical procedure, whether or not related to suspected endometriosis (ovarian cyst, uterine malformation) and with evocative symptoms of endometriosis.

Brief summary: ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium.

The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis.

The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis.

The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines.

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
  * Completion of a self-questionnaire on symptom and quality-of-life.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 10 and 19 years,
* Patient over 18 or legal representatives of patient under 18 who has dated and signed the consent form,
* Patient with pelvic MRI available and conduct within 12 months prior to inclusion,
* Patient from one of the 3 study populations:

  * A formal endometriosis diagnosed by clinical examination and imaging or
  * With prescription for coelioscopy because of a discrepancy between clinical and radiological findings or
  * A surgical indication for a pathology of the small pelvis other than endometriosis, in adolescents with suspected endometriosis faced with symptoms suggestive (dysmenorrhea, chronic or cyclic pelvic pain, urinary disorders cycle-dependent)
* Patient affiliated to the healthcare system.

Exclusion Criteria:

* Known pregnancy in progress,
* Known infection with the human immunodeficiency virus (HIV),
* Personal history of cancer,
* Adolescent subject to a protective measure or placed adolescent,
* Adolescent or her legal representatives presenting important difficulties in reading French language,
* Patient or her legal representatives who have objected to the collection of her data,
* Patient participating in an interventional study with drug or medical device or in the exclusion period of an interventional study
* Patient who has participated or is participating in another study evaluating miRNA in endometriosis.

Primary outcomes:
measure: Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative).
timeFrame: Through the end of study inclusions, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Hôpital de la Citadelle
city: Aix-en-Provence
country: France
facility: Centre chirurgical L'Avancée
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Caen
country: France
facility: CHU Caen
city: Marseille
country: France
facility: AP-HM Hôpital de la Conception
city: Nîmes
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: APHP, Hôpital Cochin Port Royal
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Bern
country: Switzerland
facility: Universitätsklinik für Frauenheilkunde, Inselspital Bern
Study officials:
References: