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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05928442
Other study ID # 2023-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2023
Est. completion date November 2024

Study information

Verified date April 2024
Source ZIWIG
Contact Philippe Descamps, Pr
Phone 02 41 35 48 99
Email phdescamps@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 10 Years to 19 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Country Name City State
Belgium Hôpital de la Citadelle Liège
France 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 APHP, Hôpital Cochin Port Royal Paris
France Hôpital Tenon Paris
France CHU Lyon Sud Pierre-Bénite
France CHU Rennes Rennes
France CHU Rouen Rouen
Switzerland Universitätsklinik für Frauenheilkunde, Inselspital Bern Bern

Sponsors (3)

Lead Sponsor Collaborator
ZIWIG iGenSeq, Monitoring Force Group

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

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