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Evaluation of miRNAs in Endometriosis (ENDOmiARN)

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ClinicalTrials.gov Identifier: NCT04728152
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Sofiane Bendifallah, Groupe expert en endometriose-6 centre expert en endometriose

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
Endometriosis Endometriosis Fertility Endometriosis-related Pain Other: Blood and salivar test

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Evaluation of miRNAs in Endometriosis
Estimated Study Start Date : January 27, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis


Intervention Details:
  • Other: Blood and salivar test

    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).


Primary Outcome Measures :
  1. Describe the evolution of miRNA expression (blood and salivary) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ; [ Time Frame: 1 month ]
  2. To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis; [ Time Frame: 1 time ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728152


Contacts
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Contact: SOFIANE BENDIFALLAH, MD PHD 0156015410 sofiane.bendifallah@aphp.fr
Contact: EMILE DARAI, Prof 0156017751 emile.darai@aphp.fr

Locations
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France
Sofiane Bendifallah Recruiting
Paris, France, 75020
Contact: SOFIANE BENDIFALLAH    0156015410    sofiane.bendifallah@aphp.fr   
Sponsors and Collaborators
Groupe expert en endometriose-6 centre expert en endometriose
Investigators
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Study Director: EMILE DARAI, PROF Centre Expert En Endométriose (C3E)
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Responsible Party: Sofiane Bendifallah, MD, PhD, Groupe expert en endometriose-6 centre expert en endometriose
ClinicalTrials.gov Identifier: NCT04728152    
Other Study ID Numbers: n° Id-RCB 2020-A03297-32
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofiane Bendifallah, Groupe expert en endometriose-6 centre expert en endometriose:
endometriosis
miRNA
Additional relevant MeSH terms:
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Endometriosis