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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
| iGenSeq | UNKNOWN |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Endometriosis" patients | Patient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients |
| |
| "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 |
| |
| "Surgery" patients | Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis. At least 20 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in vitro diagnostic medical device | Device | Collection of 2 saliva samples at inclusion. |
|
| 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). | Confirm the interest of EndoTest® in adolescents with suspected endometriosis | Through the end of study inclusions, an average of 1 year |
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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:
Patient affiliated to the healthcare system.
Exclusion Criteria:
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The study population made up of 3 differents adolescents populations:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Descamps, Pr | Contact | 02 41 35 48 99 | +33 | phdescamps@chu-angers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Citadelle | Recruiting | Liège | Belgium |
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Saliva
| Completion of a self-questionnaire | Behavioral | Completion of a self-questionnaire on symptom and quality-of-life at inclusion. |
|
| in vitro diagnostic medical device | Device | Collection of 1 saliva sample at the follow-up visit. |
|
| Centre chirurgical L'Avancée | Recruiting | Aix-en-Provence | 13090 | France |
|
| CHU Angers | Recruiting | Angers | 49033 | France |
|
| Clinique Tivoli-Ducos | Recruiting | Bordeaux | 33000 | France |
|
| CHU Caen | Recruiting | Caen | 14033 | France |
|
| AP-HM Hôpital de la Conception | Recruiting | Marseille | 13005 | France |
|
| CHU Caremeau | Recruiting | Nîmes | 30029 | France |
|
| Hôpital Tenon | Recruiting | Paris | 75020 | France |
|
| APHP, Hôpital Cochin Port Royal | Recruiting | Paris | France |
|
| CHU Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| CHU Rennes | Recruiting | Rennes | 35000 | France |
|
| CHU Rouen | Recruiting | Rouen | France |
|
| Universitätsklinik für Frauenheilkunde, Inselspital Bern | Recruiting | Bern | Switzerland |
|
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D011933 | Reagent Kits, Diagnostic |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007202 | Indicators and Reagents |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D004864 | Equipment and Supplies |
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