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

NCT05928442 | Recruiting

• 1 other identifier: 2023-02
• Study Type: observational
• Target: 80
• Locations: 3 countries
• Sites: 13

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.

Conditions

Endometriosis

Keywords

miRNA; RNA; Machine learning algorithms; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

"Endometriosis" patients

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

"Discordants" patients

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

"Surgery" patients

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

Interventions

in vitro diagnostic medical device DEVICE

Collection of 2 saliva samples at inclusion.

"Discordants" patients; "Endometriosis" patients; "Surgery" patients

Completion of a self-questionnaire BEHAVIORAL

Completion of a self-questionnaire on symptom and quality-of-life at inclusion.

"Discordants" patients; "Endometriosis" patients; "Surgery" patients

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population made up of 3 differents adolescents populations: * "Endometriosis" patients: diagnosis confirmed by imaging; endometriosis formally diagnosed on clinical or imaging examination (ovarian endometriosis and/or severe deep endometriosis with vaginal, lateral or colorectal involvement) * "Discordants" patients: surgical confirmation; suspected endometriosis with discordant clinical and radiological data requiring surgical care (exploratory coelioscopy) for diagnosis in routine care, based on national recommendations and after validation by in RCP * "Sugery" patients: Surgical procedure motivated by a reason other than endometriosis: adolescents with another pelvic pathology requiring a planned surgical procedure, whether or not related to suspected endometriosis (ovarian cyst, uterine malformation) and with evocative symptoms of endometriosis.

You may qualify if:

• 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 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.

You may not qualify if:

• 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 who has participated or is participating in another study evaluating miRNA in endometriosis.

Sponsors & Collaborators

• ZIWIG: lead
• Monitoring Force Group: collaborator
• iGenSeq: collaborator

Study Sites (13)

Hôpital de la Citadelle

Liège, Belgium

RECRUITING

Centre chirurgical L'Avancée

Aix-en-Provence, 13090, France

RECRUITING

CHU Angers

Angers, 49033, France

RECRUITING

Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

CHU Caen

Caen, 14033, France

RECRUITING

AP-HM Hôpital de la Conception

Marseille, 13005, France

RECRUITING

CHU Caremeau

Nîmes, 30029, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

RECRUITING

APHP, Hôpital Cochin Port Royal

Paris, France

RECRUITING

CHU Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

Universitätsklinik für Frauenheilkunde, Inselspital Bern

Bern, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Endometriosis

Interventions

Reagent Kits, Diagnostic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals; Equipment and Supplies

Central Study Contacts

Philippe Descamps, Pr

CONTACT

02 41 35 48 99; phdescamps@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: June 13, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CH (1); BE (1); FR (11)