- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728152
Evaluation of miRNAs in Endometriosis (ENDOmiARN)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
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
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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)
Time Frame: 1 month
|
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) ;
Time Frame: 1 month
|
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
|
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
|
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
|
1 time
|
Collaborators and Investigators
Investigators
- Study Director: EMILE DARAI, PROF, Centre Expert En Endométriose (C3E)
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- n° Id-RCB 2020-A03297-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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