Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373822
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-15
Brief Title:
New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
Sponsor:
Université Catholique de Louvain
Organization:
Université Catholique de Louvain
Study Overview
Official Title:
New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ADENO-MIRNA
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
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
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 n25 including patients diagnosed with adenomyosis by MRI andor ultrasonography prior surgery and the control group n25 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 -80C until further use To isolate circulating miRNAs a commercial kit Qiagen miRNeasy serumplasma 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 andor targeted for development of new therapeutic options
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 n25 including patients diagnosed with adenomyosis by MRI andor ultrasonography prior surgery and the control group n25 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 -80C until further use To isolate circulating miRNAs a commercial kit Qiagen miRNeasy serumplasma 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 andor targeted for development of new therapeutic options
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