Evaluation of miRNAs in Endometriosis

NCT04728152 | Unknown DMC

• 1 other identifier: n° Id-RCB 2020-A03297-32
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Endometriosis Fertility; Endometriosis-related Pain

Keywords

endometriosis; miRNA

Outcome Measures

Primary Outcomes (1)

• Describe the evolution of miRNA expression (blood and salivary)

  1 month

Secondary Outcomes (4)

• 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

Interventions

Blood and salivar test OTHER

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 Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe expert en endometriose-6 centre expert en endometriose: lead

Study Sites (1)

Sofiane Bendifallah

Paris, 75020, France

RECRUITING

Related Publications (1)

• Dabi Y, Suisse S, Marie Y, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Forlani S, Bouteiller D, Touboul C, Puchar A, Bendifallah S, Darai E. New class of RNA biomarker for endometriosis diagnosis: The potential of salivary piRNA expression. Eur J Obstet Gynecol Reprod Biol. 2023 Dec;291:88-95. doi: 10.1016/j.ejogrb.2023.10.015. Epub 2023 Oct 13.

  PMID: 37857147 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• EMILE DARAI, PROF

  Centre Expert En Endométriose (C3E)

  STUDY DIRECTOR

Central Study Contacts

SOFIANE BENDIFALLAH, MD PHD

CONTACT

0156015410; sofiane.bendifallah@aphp.fr

EMILE DARAI, Prof

CONTACT

0156017751; emile.darai@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 28, 2021
• Study Start: January 27, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)