Endometriosis
Conditions
Keywords
miRNA, RNA, Machine learning algorithms, Adolescents
Brief 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.
Interventions
DEVICEin vitro diagnostic medical device
Collection of 2 saliva samples at inclusion.
BEHAVIORALCompletion of a self-questionnaire
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
Sponsors
Monitoring Force Group
iGenSeq
ZIWIG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative). | Through the end of study inclusions, an average of 1 year | Confirm the interest of EndoTest® in adolescents with suspected endometriosis |
Countries
Belgium, France, Switzerland
Contacts
Primary ContactPhilippe Descamps, Pr
Outcome results
None listed