Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414720
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-05
Brief Title:
Salivary microRNA in Endometriosis Correlation With Response to Progestin Therapy
Sponsor:
University of Udine
Organization:
University of Udine
Study Overview
Official Title:
Salivary MicroRNA in Endometriosis Correlation With Progestin Treatment Response A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOmiRNA
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None