Clinical trial NCT06414720: Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy
Official title: Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: Endometriosis
miRNA
Progesterone resistance
Lead sponsor: University of Udine
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who meet the inclusion criteria.

Brief summary: 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.

Detailed description: In recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. Among these, microRNA (miRNA) is emerging as a promising option. Despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among miRNAs. This study aims, therefore, to identify salivary miRNA signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine will be enrolled. The investigators will ask them for a salivary sample before starting the progestin therapy. After 4 months from the beginning, the response will be evaluated. The researchers will evaluate the differences between salivary miRNA of the responders vs non-responders.

Eligibility criteria: 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

Primary outcomes:
measure: response to the progestin therapy
timeFrame: 0 (pre-therapy) - 4 months (after therapy)
measure: changes in quality of life
timeFrame: 0 (pre-therapy) - 4 months (after therapy)
measure: differences in salivary miRNoma
timeFrame: sample collection at time 0, analysis after time 4
Secondary outcomes:
Other outcomes:
Locations:
city: Udine
country: Italy
facility: University of Udine
state: UD
Study officials:
affiliation: University of Udine
name: Giuseppe Vizzielli, prof
role: STUDY_CHAIR
References:
citation: 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.
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.
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.