New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs (ADENO-MIRNA)

Objectives:

To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methods

Hypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the disease

Study Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences.

Study Overview

• Status: Recruiting
• Conditions: Adenomyosis
• Intervention / Treatment: Diagnostic test: Circulating-mirna

Detailed Description

The present study is based on previous research pointing out that circulating miRNAs are abnormally expressed in several pathologies including endometriosis, and can be used as a handy diagnostic tool in the clinical setting. The investigators hypothesize that miRNAs are differentially expressed in adenomyosis as well and could serve as noninvasive biomarkers to diagnose the condition. To test this hypothesis, the investigators plan to conduct a pilot study on 50 patients (25 adenomyosis patients and 25 healthy subjects), in order to compare expression of different miRNAs between the groups and determine a suitable diagnostic panel. There is approximatively 25 women undergoing hysterectomy for adenomyosis over the course of a year at the CUSL. It is also a necessary population in order to obtain statistically analyzable datas. This panel may be tested in the future in a larger population for validation purposes.

Blood samples (10 ml) will be collected the day of the surgery by the anesthetist from female patients visiting the CUSL for the purpose of hysterectomy. Patients will be subdivided into two groups, namely the study group (n=25) including patients diagnosed with adenomyosis by MRI and/or ultrasonography prior surgery and the control group (n=25) consisting of patients with pathologies unrelated to the endometrium. After samples registration in CUSL biobank, they will be transferred to the research laboratory and serum will be collected immediately by centrifuging at 2500 rpm for 15 min at 4° C followed by storage at -80°C until further use. To isolate circulating miRNAs, a commercial kit (Qiagen miRNeasy serum/plasma kit) will be used and cDNA will be then synthesized using appropriate kit (Qiagen miScript II RT). Commercial miRNA arrays will be used to simultaneously quantify expression of around 1000 miRNAs and compare their expression profiles between adenomyosis patients and unaffected subjects. Individual RT-qPCR reactions will be then conducted to validate the results. Differentially expressed microRNAs in adenomyosis will be further analyzed to determine their target genes and subsequent affected biological functions, using appropriate databases (TargetScan and miRTarBase). This experimental approach will allow us to identify abnormally expressed miRNAs in adenomyosis compared to disease-free women. These can then be used as noninvasive biomarkers of the pathology and/or targeted for development of new therapeutic options.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Belgium
  • Woluwe-Saint-Lambert
    • Brussel, Woluwe-Saint-Lambert, Belgium, 1200
      • Recruiting
      • CUSL
      • Contact: Emilie Wacheul, MD; Phone Number: 027645246; Email: emilie.wacheul@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female patients visiting the service de Gynécologie of the CUSL for the purpose of surgical intervention in the context of uterine adenomyosis

Description

Inclusion Criteria:

• Age ≥ 18 years
• Pre-menopausal

Exclusion Criteria:

• HIV or Hepatitis-positive
• having participated in another clinical study in the 12 months prior to recruitment
• presenting symptoms of endometriosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group (N=25); Female patients visiting the service de Gynécologie of the CUSL for the purpose of intervention in the context of a benign gynecological issue (myomectomy, endometrial resection etc).; Age ≥ 18 years; Pre-menopausal; Not HIV or Hepatitis-positive; Not having participated in another clinical study in the 12 months prior to recruitment; Not presenting symptoms of adenomyosis and/or endometriosis	Diagnostic test: Circulating-mirna; A single blood sample (1 tube of 10 ml) on the day of the patient's visit to the service de Gynécologie of the CUSL.
Adenomyosis group (N=25); Female patients visiting the service de Gynécologie of the CUSL for the purpose of surgical intervention in the context of uterine adenomyosis.; Age ≥ 18 years; Pre-menopausal; Not HIV or Hepatitis-positive; Not having participated in another clinical study in the 12 months prior to recruitment; Not presenting symptoms of endometriosis	Diagnostic test: Circulating-mirna; A single blood sample (1 tube of 10 ml) on the day of the patient's visit to the service de Gynécologie of the CUSL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating-miRNA as diagnostic biomarkers	Sequencing miRNA	Throughout the entire study, aproximately during 6,5 years

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Adenomyosis
• Other Study ID Numbers: 2024/18JAN/028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No