Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent

Recruiting

• Conditions: Endometriosis
• Interventions: Device: in vitro diagnostic medical device; Behavioral: Completion of a self-questionnaire

• Registration Number: NCT05928442
• Lead Sponsor: ZIWIG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-13
• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-06
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"Endometriosis" patients	Completion of a self-questionnaire	Patient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients
"Surgery" patients	Completion of a self-questionnaire	Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis. At least 20 patients
"Endometriosis" patients	in vitro diagnostic medical device	Patient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients
"Discordants" patients	Completion of a self-questionnaire	Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical examination and imaging data, AND a surgical indication. At least 20 patients
"Discordants" patients	in vitro diagnostic medical device	Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical examination and imaging data, AND a surgical indication. At least 20 patients
"Surgery" patients	in vitro diagnostic medical device	Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis. At least 20 patients

Primary Outcome Measures

Name	Time	Method
Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative).	Through the end of study inclusions, an average of 1 year	Confirm the interest of EndoTest® in adolescents with suspected endometriosis

Trial Locations

Locations (13)

Clinique Tivoli-Ducos; 🇫🇷 Bordeaux, France

Hôpital de la Citadelle; 🇧🇪 Liège, Belgium

CHU Caen; 🇫🇷 Caen, France

CHU Rennes; 🇫🇷 Rennes, France

AP-HM Hôpital de la Conception; 🇫🇷 Marseille, France

CHU Caremeau; 🇫🇷 Nîmes, France

CHU Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre chirurgical L'Avancée; 🇫🇷 Aix-en-Provence, France

CHU Angers; 🇫🇷 Angers, France

Hôpital Tenon; 🇫🇷 Paris, France

APHP, Hôpital Cochin Port Royal; 🇫🇷 Paris, France

CHU Rouen; 🇫🇷 Rouen, France

Universitätsklinik für Frauenheilkunde, Inselspital Bern; 🇨🇭 Bern, Switzerland