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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral, Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Hôpital de la Citadelle
RECRUITING
Liège
France
Centre chirurgical L'Avancée
RECRUITING
Aix-en-provence
CHU Angers
RECRUITING
Angers
Clinique Tivoli-Ducos
RECRUITING
Bordeaux
CHU Caen
RECRUITING
Caen
AP-HM Hôpital de la Conception
RECRUITING
Marseille
CHU Caremeau
RECRUITING
Nîmes
APHP, Hôpital Cochin Port Royal
RECRUITING
Paris
Hôpital Tenon
RECRUITING
Paris
CHU Lyon Sud
RECRUITING
Pierre-bénite
CHU Rennes
RECRUITING
Rennes
CHU Rouen
RECRUITING
Rouen
Switzerland
Universitätsklinik für Frauenheilkunde, Inselspital Bern
RECRUITING
Bern
Contact Information
Primary
Philippe Descamps, Pr
phdescamps@chu-angers.fr
02 41 35 48 99
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2024-11
Participants
Target number of participants: 80
Treatments
Endometriosis patients
Patient with a formal endometriosis diagnosed by clinical examination and imaging.~At least 20 patients
Discordants patients
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
Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis.~At least 20 patients
Related Therapeutic Areas
Sponsors
Collaborators: Monitoring Force Group, iGenSeq
Leads: ZIWIG

This content was sourced from clinicaltrials.gov