New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
ADENO-MIRNA
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2024
CompletedFirst Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
April 22, 2024
April 1, 2024
7.5 years
April 15, 2024
April 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Circulating-miRNA as diagnostic biomarkers
Sequencing miRNA
Throughout the entire study, aproximately during 6,5 years
Study Arms (2)
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
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
Interventions
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.
Eligibility Criteria
Female patients visiting the service de Gynécologie of the CUSL for the purpose of surgical intervention in the context of uterine adenomyosis
You may qualify if:
- Age ≥ 18 years
- Pre-menopausal
You may not qualify if:
- HIV or Hepatitis-positive
- having participated in another clinical study in the 12 months prior to recruitment
- presenting symptoms of endometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CUSL
Brussels, Woluwe-Saint-Lambert, 1200, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 18, 2024
Study Start
March 21, 2024
Primary Completion (Estimated)
September 1, 2031
Study Completion (Estimated)
September 1, 2031
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share