Multiple SclerosisNCT04772495
miRNA Biomarkers in Multiple Sclerosis
An observational study of Multiple Sclerosis and miRNA, run by University of Gaziantep.
Trial summary
Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, miRNA, Epigenetic
- What is being tested?
- miRNA
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who had been diagnosed with Multiple sclerosis and healthy male and female
Who may be able to join
- The age of 25 years and above
- at least one Central Nervous System (CNS) demyelination event
Who cannot join
- with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, Thalassemia, Sickle cell disease, iron deficiency, and B12 deficiency
About this study
Official title: The Potential Candidate miRNA Biomarkers in Multiple Sclerosis
Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential targets for biomarkers and new therapeutic approaches. In this study, we evaluated the dysregulation of miRNA expression levels at MS and MS stages. We also discussed the potential of these miRNAs to be biomarkers and/or therapeutic targets in MS.
- Conditions
- Multiple Sclerosis, miRNA, Epigenetic, Biomarker
- Being tested
- miRNA
- Keywords
- Multiple sclerosis, miRNA biomarkers, peripheral blood molecular diagnostics
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNAGenetic
miRNA effect on Multiple sclerosis pathology
| Study group | Role | What they receive |
|---|---|---|
| Study group | with Multiple sclerosis Receives: Genetic: miRNA | |
| Control group | not Multiple sclerosis Receives: Genetic: miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression
peripheral blood miRNA expressions
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startMay 2015
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Görücü Yılmaz, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772495
- Sponsor's protocol ID
- 2015/7
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Candidate miRNA Biomarkers in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04772495
- Acronym / sponsor ID
- 2015/7
- Conditions
- Multiple Sclerosis, miRNA, Epigenetic, Biomarker
- Keywords
- Multiple sclerosis, miRNA biomarkers, peripheral blood molecular diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Feb 2021 (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.
Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential targets for biomarkers and new therapeutic approaches. In this study, we evaluated the dysregulation of miRNA expression levels at MS and MS stages. We also discussed the potential of these miRNAs to be biomarkers and/or therapeutic targets in MS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: miRNAwith Multiple sclerosis |
| Control group | – | Genetic: miRNAnot Multiple sclerosis |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who had been diagnosed with Multiple sclerosis and healthy male and female
Key inclusion criteria (2 listed)
- The age of 25 years and above
- at least one Central Nervous System (CNS) demyelination event
Key exclusion criteria (1 listed)
- with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, Thalassemia, Sickle cell disease, iron deficiency, and B12 deficiency
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 |
|---|---|---|
| miRNAmiRNA effect on Multiple sclerosis pathology | Genetic | Control group, Study group |
Primary outcome
miRNA expression
Time frame: intraoperative
peripheral blood miRNA expressions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and miRNA, run by University of Gaziantep.
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 1 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: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression (time frame: intraoperative). 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 26 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.