Endometriosis Clinical Trial
— ENDOmiRNAOfficial title:
Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study
NCT number | NCT06414720 |
Other study ID # | ENDOmiRNA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 22, 2024 |
Est. completion date | May 1, 2025 |
This study aims to analyze the salivary miRNA specific for patients diagnosed with endometriosis, specifically evaluating the miRNA profile of patients who respond versus those who do not respond to progestin therapy. Ninety patients attending the Chronic Pelvic Pain Clinic will be recruited, and they will be asked to provide a saliva sample before starting medical therapy. The response to the therapy will be evaluated after 4 months from the beginning of the therapy itself.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | INCLUSION CRITERIA - Age > 18 years - Fertile age - Clinical-ultrasound diagnosis or histological diagnosis of endometriosis - Informed consent EXCLUSION CRITERIA - Pregnancy - Pre-menarcheal or post-menopausal status - Chronic pelvic pain syndrome with or without central sensitization assessed with the Central Sensitization Inventory Test (CSI) - Neoplasia, diabetes, BMI > 30 kg/m2, coagulopathies, autoimmune diseases, or other conditions that may affect salivary miRNA measurement - Currently undergoing progestin therapy |
Country | Name | City | State |
---|---|---|---|
Italy | University of Udine | Udine | UD |
Lead Sponsor | Collaborator |
---|---|
University of Udine |
Italy,
Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612. — View Citation
Hon JX, Wahab NA, Karim AKA, Mokhtar NM, Mokhtar MH. MicroRNAs in Endometriosis: Insights into Inflammation and Progesterone Resistance. Int J Mol Sci. 2023 Oct 9;24(19):15001. doi: 10.3390/ijms241915001. — View Citation
Zhang P, Wang G. Progesterone Resistance in Endometriosis: Current Evidence and Putative Mechanisms. Int J Mol Sci. 2023 Apr 10;24(8):6992. doi: 10.3390/ijms24086992. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response to the progestin therapy | response to 2 mg dienogest therapy evaluated with NRS (numeric rating scale) scale assessed for acyclic pain, dyspareunia, dyschezia, dysmenorrhea, periovulatory pain | 0 (pre-therapy) - 4 months (after therapy) | |
Primary | changes in quality of life | changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36) | 0 (pre-therapy) - 4 months (after therapy) | |
Primary | differences in salivary miRNoma | Once it is established which patients are responders and which are non-responders, differential salivary miRNAs between the two groups will be identified via sequencing. The miRNA reverse transcription reaction will be performed using the reverse transcription kit TaqMan MicroRNA (Applied Biosystems). The reverse transcription product will be used for Real-time PCR. The small nucleolar RNA RNU6 will be used as an endogenous control. The protocol of Amplification will be carried out using the LightCycler 480 instrument (Roche). For each miRNA, qPCR will be performed in duplicate. The relative expression levels of miRNAs will be calculated using the 2-??Ct method. | sample collection at time 0, analysis after time 4 |
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