Multicenter Validation of the Salivary miRNA Signature of Endometriosis
Study Details
Study Description
Brief Summary
ENDOmiARN Salive Test is a multicentre external validation study of a salivary signature of endometriosis carried out in France in Obstetrics and Reproductive Medicine departments, in order to evaluate its performance and discuss its use in clinical practice. The clinical application is to significantly reduce the time to diagnosis and improve the care pathway for endometriosis.
The study population is made up of women aged 18 to 43 years with formally diagnosed endometriosis or suspected endometriosis who are already receiving either medical (MAP) or surgical treatment as part of their routine care.
The patients concerned by the study are managed without any change in the care pathway, nor any change in the therapeutic indications, nor any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the HAS recommendations.
In this study, the management and follow-up of patients :
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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,
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Are not modified in comparison with the usual follow-up, except for the performance of :
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Collection of saliva
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Electronic collection of the answers to the questionnaires completed by the patient
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- At least a 90% Sensitivity (True Positive Rate) of Endometriosis diagnotic confirmation using a miRNA signature [Through the end of study inclusions, an average of 1 year]
External validation of the salivary signature of endometriosis miRNAs
- At least a 90% Specificity (True Negative Rate) of Endometriosis diagnotic confirmation using a miRNA signature [Through the end of study inclusions, an average of 1 year]
External validation of the salivary signature of endometriosis miRNAs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged between 18 and 43 years,
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Patient having dated and signed the consent form,
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Patient affiliated to the French health system,
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Patient with formal endometriosis diagnosed by clinical examination and imaging or suspected endometriosis for which the diagnosis is the source of a discrepancy between the clinical and radiological data,
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Patient with an indication for medically assisted procreation (MAP) or surgery validated by RCP (in routine care),
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Patient who has undergone pelvic MRI,
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Patient having completed validated symptom and quality of life questionnaires.
Exclusion Criteria:
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Pregnant patient,
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Patient infected with the human immunodeficiency virus (HIV),
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Patient with significant difficulties in reading or writing the French language,
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Patient with a personal history of cancer,
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Patient unable to comply with study and/or follow-up procedures,
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Patient who has objected to the collection of her data.
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Patient participating in another clinical research study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Caen | Caen | Calvados | France | 14000 |
| 2 | Clinique Tivoli | Bordeaux | Gironde | France | 33000 |
| 3 | CHU Angers | Angers | France | 49933 | |
| 4 | CH Bastia | Bastia | France | 20600 | |
| 5 | HCL | Lyon | France | 69000 | |
| 6 | Groupe Hospitalier Saint Josef | Paris | France | 75014 | |
| 7 | Centre d'imagerie Manin Crimée | Paris | France | 75019 | |
| 8 | CHU Tenons | Paris | France | 75020 | |
| 9 | CHU Rennes | Rennes | France | 35000 |
Sponsors and Collaborators
- ZIWIG
- Monitoring Force Group
- iGenSeq
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FR-21-001