Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent
NCT ID: NCT05928442
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2023-06-13
2024-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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"Endometriosis" patients
Patient with a formal endometriosis diagnosed by clinical examination and imaging.
At least 20 patients
in vitro diagnostic medical device
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaire
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
"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
in vitro diagnostic medical device
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaire
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
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
in vitro diagnostic medical device
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaire
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
in vitro diagnostic medical device
Collection of 1 saliva sample at the follow-up visit.
Interventions
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in vitro diagnostic medical device
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaire
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
in vitro diagnostic medical device
Collection of 1 saliva sample at the follow-up visit.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
10 Years
19 Years
FEMALE
No
Sponsors
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Monitoring Force Group
INDUSTRY
iGenSeq
UNKNOWN
ZIWIG
INDUSTRY
Responsible Party
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Locations
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Hôpital de la Citadelle
Liège, , Belgium
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
Hôpital Tenon
Paris, , France
APHP, Hôpital Cochin Port Royal
Paris, , France
CHU Lyon Sud
Pierre-Bénite, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
Universitätsklinik für Frauenheilkunde, Inselspital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Michelle Nisole, Pr
Role: primary
Christine Lévêque, Dr
Role: primary
Horace Roman, Pr
Role: primary
Raffaèle Fauvet, Pr
Role: primary
Lise Amart, Dr
Role: primary
Lucie Allègre, Dr
Role: primary
Pietro Santulli, Pr
Role: primary
Krystel Nyangoh Timoh, Dr
Role: primary
Clotilde Hennetier, MD
Role: primary
Michael Mueller, Pr
Role: primary
Other Identifiers
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2023-02
Identifier Type: -
Identifier Source: org_study_id
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