AdenomyosisADENO-MIRNANCT06373822
New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
An observational study of Adenomyosis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Circulating-mirna
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Mar 2024to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients visiting the service de Gynécologie of the CUSL for the purpose of surgical intervention in the context of uterine adenomyosis
Who may be able to join
- Age ≥ 18 years
- Pre-menopausal
Who cannot join
- HIV or Hepatitis-positive
- having participated in another clinical study in the 12 months prior to recruitment
- presenting symptoms of endometriosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CUSL
Brussels, Woluwe-Saint-Lambert, 1200
Emilie Wacheul, MD, 027645246, emilie.wacheul@uclouvain.be
About this study
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.
Read the 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.
- Conditions
- Adenomyosis
- Being tested
- Circulating-mirna
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating-mirnaDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Circulating-mirna | |
| 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 Receives: Diagnostic Test: Circulating-mirna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating-miRNA as diagnostic biomarkers
Sequencing miRNA
Measured: Throughout the entire study, aproximately during 6,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start21 Mar 2024
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373822
- Sponsor's protocol ID
- 2024/18JAN/028
- Acronym
- ADENO-MIRNA
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
- ClinicalTrials.gov ID
- NCT06373822
- Acronym / sponsor ID
- ADENO-MIRNA / 2024/18JAN/028
- Conditions
- Adenomyosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (N=25) | – | Diagnostic Test: Circulating-mirnaFemale 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) | – | Diagnostic Test: Circulating-mirnaFemale 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients visiting the service de Gynécologie of the CUSL for the purpose of surgical intervention in the context of uterine adenomyosis
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Pre-menopausal
Key exclusion criteria (3 listed)
- HIV or Hepatitis-positive
- having participated in another clinical study in the 12 months prior to recruitment
- presenting symptoms of endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating-mirnaA single blood sample (1 tube of 10 ml) on the day of the patient's visit to the service de Gynécologie of the CUSL. | Diagnostic test | Adenomyosis group (N=25), Control group (N=25) |
Primary outcome
Circulating-miRNA as diagnostic biomarkers
Time frame: Throughout the entire study, aproximately during 6,5 years
Sequencing miRNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating-miRNA as diagnostic biomarkers (time frame: Throughout the entire study, aproximately during 6,5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.