An observational study in Endometriosis, sponsored by ZIWIG. Recruiting at 13 sites in 3 countries. Open to female participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by ZIWIG · Observational
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 modified in comparison with the usual follow-up, except for the performance of :
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 80 is below the median of 128 across 344 observational studies indexed under Endometriosis.
Browse Endometriosis studies →ZIWIG is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population made up of 3 differents adolescents populations:
Patient from one of the 3 study populations:
Exclusion Criteria:
Patient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients
Device: in vitro diagnostic medical device · Behavioral: 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
Device: in vitro diagnostic medical device · Behavioral: 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
Device: in vitro diagnostic medical device · Behavioral: Completion of a self-questionnaire
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
Collection of 1 saliva sample at the follow-up visit.
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
Time frame: Through the end of study inclusions, an average of 1 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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