Evaluation of miRNAs in Endometriosis (ENDOmiARN)

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 Overview

• Status: Recruiting
• Conditions: Endometriosis; Endometriosis-related Pain; Endometriosis Fertility
• Intervention / Treatment: Other: Blood and salivar test

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: SOFIANE BENDIFALLAH, MD PHD; Phone Number: 0156015410; Email: sofiane.bendifallah@aphp.fr
• Study Contact Backup: Name: EMILE DARAI, Prof; Phone Number: 0156017751; Email: emile.darai@aphp.fr

Study Locations

• France
  • Paris, France, 75020
    • Recruiting
    • Sofiane Bendifallah
    • Contact: SOFIANE BENDIFALLAH; Phone Number: 0156015410; Email: sofiane.bendifallah@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Describe the evolution of miRNA expression (blood and salivary)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe expert en endometriose-6 centre expert en endometriose
• Investigators: Study Director: EMILE DARAI, PROF, Centre Expert En Endométriose (C3E)

Study record dates

Study Major Dates

• Study Start (Anticipated): January 27, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: miRNA; endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: n° Id-RCB 2020-A03297-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No