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

April 9, 2024 updated by: ZIWIG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium
        • Recruiting
        • Hôpital de la Citadelle
        • Contact:
          • Michelle Nisole, Pr
  • France
      • Aix-en-Provence, France, 13090
        • Recruiting
        • Centre chirurgical L'Avancée
        • Contact:
          • Christine Lévêque, Dr
      • Angers, France, 49033
      • Bordeaux, France, 33000
        • Recruiting
        • Clinique TIVOLI-DUCOS
        • Contact:
          • Horace Roman, Pr
      • Caen, France, 14033
        • Recruiting
        • CHU Caen
        • Contact:
          • Raffaèle Fauvet, Pr
      • Marseille, France, 13005
        • Recruiting
        • AP-HM Hôpital de la Conception
        • Contact:
          • Lise Amart, Dr
      • Nîmes, France, 30029
        • Recruiting
        • CHU Caremeau
        • Contact:
          • Lucie Allègre, Dr
      • Paris, France, 75020
      • Paris, France
        • Recruiting
        • APHP, Hôpital Cochin Port Royal
        • Contact:
          • Pietro Santulli, Pr
      • Pierre-Bénite, France, 69310
      • Rennes, France, 35000
        • Recruiting
        • Chu Rennes
        • Contact:
          • Krystel Nyangoh Timoh, Dr
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Clotilde Hennetier, MD
  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • Universitätsklinik für Frauenheilkunde, Inselspital Bern
        • Contact:
          • Michael Mueller, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
"Endometriosis" patients

Patient with a formal endometriosis diagnosed by clinical examination and imaging.

At least 20 patients
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.
"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
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.
"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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative).
Time Frame: Through the end of study inclusions, an average of 1 year
Confirm the interest of EndoTest® in adolescents with suspected endometriosis
Through the end of study inclusions, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIWIG

Collaborators

Monitoring Force Group
iGenSeq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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