Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy (ENDOmiRNA)

May 9, 2024 updated by: Giuseppe Vizzielli, University of Udine

Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometriosis patients
Patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who have not yet started medical therapy.
Drug: Dienogest 2 MG
The patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis.
Other Names:
  • visanne
  • zafrilla
  • devicius
  • endodien

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response to the progestin therapy
Time Frame: 0 (pre-therapy) - 4 months (after 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)
changes in quality of life
Time Frame: 0 (pre-therapy) - 4 months (after therapy)
changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36)
0 (pre-therapy) - 4 months (after therapy)
differences in salivary miRNoma
Time Frame: sample collection at time 0, analysis after time 4
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-ΔΔCt method.
sample collection at time 0, analysis after time 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Udine

Investigators

  • Study Chair: Giuseppe Vizzielli, prof, University of Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOmiRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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