Evaluation of miRNAs in Endometriosis

Endometriosis Clinical Trial

— ENDOmiARN  

Official title:

Evaluation of miRNAs in Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728152
• Other study ID #: n° Id-RCB 2020-A03297-32
• Status: Recruiting
• Start date: January 27, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Groupe expert en endometriose-6 centre expert en endometriose
• Contact: SOFIANE BENDIFALLAH, MD PHD
• Phone: 0156015410
• Email: sofiane.bendifallah[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Fertility
• Endometriosis-related Pain

Intervention

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).

Locations

Country	Name	City	State
France	Sofiane Bendifallah	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe expert en endometriose-6 centre expert en endometriose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the evolution of miRNA expression (blood and salivary)		1 month
Secondary	To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;		1 month
Secondary	To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;		1 time
Secondary	Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;		1 time
Secondary	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