Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent

Endometriosis Clinical Trial

— ADOmiARN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928442
• Other study ID #: 2023-02
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Endometriosis

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