Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05928442

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

Sponsor: ZIWIG

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

10 Years - 19 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2023-06-13

Completion Date

2024-11

Last Updated

2024-04-10

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (13)

Hôpital de la Citadelle

Liège, Belgium

Centre chirurgical L'Avancée

Aix-en-Provence, France

CHU Angers

Angers, France

Clinique Tivoli-Ducos

Bordeaux, France

CHU Caen

Caen, France

AP-HM Hôpital de la Conception

Marseille, France

CHU Caremeau

Nîmes, France

Hôpital Tenon

Paris, France

APHP, Hôpital Cochin Port Royal

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

Universitätsklinik für Frauenheilkunde, Inselspital Bern

Bern, Switzerland