NCT05928442

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

Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent - The ADOmiARN Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: ZIWIG · Industry
• Sex: Female
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DEVICE	in vitro diagnostic medical device	Collection of 2 saliva samples at inclusion.
BEHAVIORAL	Completion of a self-questionnaire	Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
DEVICE	in vitro diagnostic medical device	Collection of 1 saliva sample at the follow-up visit.

Timeline

• Start date: 2023-06-13
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2023-07-03
• Last updated: 2024-04-10

Locations

13 sites across 3 countries: Belgium, France, Switzerland