Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent (ADOmiARN)

Ziwig

Status: Enrolling

Conditions: Endometriosis

Treatments: Behavioral: Completion of a self-questionnaire; Device: in vitro diagnostic medical device

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05928442

2023-02

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 3 patient groups

"Endometriosis" patients

Description:

Patient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients

Treatment:

Device: in vitro diagnostic medical device

Behavioral: Completion of a self-questionnaire

Device: in vitro diagnostic medical device

"Discordants" patients

Description:

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

Treatment:

Device: in vitro diagnostic medical device

Behavioral: Completion of a self-questionnaire

Device: in vitro diagnostic medical device

"Surgery" patients

Description:

Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis. At least 20 patients

Treatment:

Device: in vitro diagnostic medical device

Behavioral: Completion of a self-questionnaire

Device: in vitro diagnostic medical device