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

NCT05928442 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-04-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Monitoring Force Group

    collaborator INDUSTRY

  • iGenSeq

    collaborator UNKNOWN

  • ZIWIG

    lead INDUSTRY

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-06-30
Completion
2024-11-30

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928442 on ClinicalTrials.gov