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Evaluation of miRNAs in Endometriosis

Evaluation of miRNAs in Endometriosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04728152
Acronym
ENDOmiARN
Enrollment
200
Registered
2021-01-28
Start date
2021-01-27
Completion date
2022-01-01
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Endometriosis Fertility, Endometriosis-related Pain

Keywords

endometriosis, miRNA

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.

Interventions

OTHERBlood 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).

Sponsors

Groupe expert en endometriose-6 centre expert en endometriose
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years

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.

Design outcomes

Primary

MeasureTime frame
Describe the evolution of miRNA expression (blood and salivary)1 month

Secondary

MeasureTime 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

Countries

France

Contacts

Primary ContactSOFIANE BENDIFALLAH, MD PHD
sofiane.bendifallah@aphp.fr0156015410
Backup ContactEMILE DARAI, Prof
emile.darai@aphp.fr0156017751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026