Evaluation of miRNAs in Endometriosis

Groupe expert en endometriose-6 centre expert en endometriose200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Endometriosis Endometriosis Fertility Endometriosis-related Pain

Interventions

Blood and salivar testOTHER

Saliva samples will be taken (concomitant with a visit carried out as part of routine care): * At the pre-therapy visit (t3), * At the post-treatment visit (at 3-6 weeks). Blood samples will be taken at two stages (concomitant with a blood test performed as part of routine care): * At the pre-therapy visit (t3), * At the post-treatment visit (at 3-6 weeks).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patient aged 18 to 43 years old, * Patient has dated and signed the consent form, * Patient affiliated with the French health care system, * 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, * Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care), * Patient who has had a pelvic MRI, * Patient who completed the symptom and quality of life questionnaires Exclusion Criteria: * Pregnant patient, * Patient infected with the human immunodeficiency virus (HIV), * Patient with significant difficulties in reading or writing the French language, * Patient with a personal history of cancer, * Patient unable to comply with study and/or follow-up procedures, * Patient who has objected to the collection of her data. * Patient participating in another clinical research study.

Locations (1)

Sofiane Bendifallah

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Describe the evolution of miRNA expression (blood and salivary)

Time frame: 1 month

Secondary Outcomes

To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;

Time frame: 1 month

To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;

Time frame: 1 time

Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;

Time frame: 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 ;

Time frame: 1 time

Central Contacts

SOFIANE BENDIFALLAH, MD PHD

CONTACT

0156015410 sofiane.bendifallah@aphp.fr

EMILE DARAI, Prof

CONTACT

0156017751 emile.darai@aphp.fr

Data from ClinicalTrials.gov

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