ENDOmiARN: Evaluation of miRNAs in Endometriosis
Study Details
Study Description
Brief Summary
We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Describe the evolution of miRNA expression (blood and salivary) [1 month]
Secondary Outcome Measures
- To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ; [1 month]
- To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis; [1 time]
- Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ; [1 time]
- Describe the relationship between miRNA expression (blood and salivary) and the level of ovarian reserve, as estimated by the AMH assay in patients of childbearing age ; [1 time]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged 18 to 43 years old,
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Patient has dated and signed the consent form,
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Patient affiliated with the French health care system,
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Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
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Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
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Patient who has had a pelvic MRI,
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Patient who completed the 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 | Sofiane Bendifallah | Paris | France | 75020 |
Sponsors and Collaborators
- Groupe expert en endometriose-6 centre expert en endometriose
Investigators
- Study Director: EMILE DARAI, PROF, Centre Expert En Endométriose (C3E)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- n° Id-RCB 2020-A03297-32