Clinical trial NCT04728152: Evaluation of miRNAs in Endometriosis
Official title: Evaluation of miRNAs in Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Endometriosis Fertility
Endometriosis-related Pain
Keywords: endometriosis
miRNA
Lead sponsor: Groupe expert en endometriose-6 centre expert en endometriose
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of women between the ages of 18 and 43 with a formal endometriosis diagnosis or suspicion of endometriosis.

Patients in the study are already receiving routine medical (PMA) or surgical care in the Gynecology-Obstetrics and Reproductive Medicine Department of the hospital. All of these patients already benefit from a validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical RCP or fertility).

The patients concerned by the study are treated without any change in the course of care, nor modification of the therapeutic indications, nor modification of the diagnostic tests (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Describe the evolution of miRNA expression (blood and salivary)
timeFrame: 1 month
Secondary outcomes:
measure: To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;
timeFrame: 1 month
measure: To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;
timeFrame: 1 time
measure: Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;
timeFrame: 1 time
measure: 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 ;
timeFrame: 1 time
Other outcomes:
Locations:
city: Paris
country: France
facility: Sofiane Bendifallah
Study officials:
affiliation: Centre Expert En Endométriose (C3E)
name: EMILE DARAI, PROF
role: STUDY_DIRECTOR
References: