Using saliva to help diagnose endometriosis in adolescents
Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent - The ADOmiARN Study
ZIWIG · NCT05928442
This study is testing if a new saliva test can help doctors diagnose endometriosis in girls and young women aged 10 to 19 who might have the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | Female |
| Sponsor | ZIWIG (industry) |
| Locations | 13 sites (Liège and 12 other locations) |
| Trial ID | NCT05928442 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the EndoTest® diagnostic device in adolescents aged 10 to 19 years who are suspected of having endometriosis. Conducted across multiple centers in France and Belgium, the study allows for the normal management of patients without altering their care pathways. Participants will complete a self-questionnaire and undergo necessary imaging and biological examinations as per national guidelines. The study focuses on confirming the diagnostic utility of salivary biomarkers in this population.
Who should consider this trial
Good fit: Ideal candidates are females aged 10 to 19 years with suspected or diagnosed endometriosis.
Not a fit: Patients who are currently pregnant or have a known HIV infection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of endometriosis in adolescents, improving their healthcare outcomes.
How similar studies have performed: While the use of salivary biomarkers is a novel approach, similar studies have shown promise in other diagnostic contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Liège and 12 other locations
- Hôpital de la Citadelle — Liège, Belgium (RECRUITING)
- Centre chirurgical L'Avancée — Aix-en-Provence, France (RECRUITING)
- CHU Angers — Angers, France (RECRUITING)
- Clinique Tivoli-Ducos — Bordeaux, France (RECRUITING)
- CHU Caen — Caen, France (RECRUITING)
- AP-HM Hôpital de la Conception — Marseille, France (RECRUITING)
- CHU Caremeau — Nîmes, France (RECRUITING)
- Hôpital Tenon — Paris, France (RECRUITING)
- APHP, Hôpital Cochin Port Royal — Paris, France (RECRUITING)
- CHU Lyon Sud — Pierre-Bénite, France (RECRUITING)
- CHU Rennes — Rennes, France (RECRUITING)
- CHU Rouen — Rouen, France (RECRUITING)
- Universitätsklinik für Frauenheilkunde, Inselspital Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Philippe Descamps, Pr
- Email: phdescamps@chu-angers.fr
- Phone: 02 41 35 48 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, miRNA, RNA, Machine learning algorithms, Adolescents