Degeneration Disc IntervertebralMIRADISCNCT07114497
Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, excised and Diagnostic work up in people with Degeneration Disc Intervertebral and miRNA, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
Aim of the Study: The aim of this study is to determine the expression levels of candidate microRNAs (miRNAs) expressed in human degenerated intervertebral disc tissues. In line with this objective, our specific goals are outlined below: Objectives: Objective 1: To include patients diagnosed with lumbar disc… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degeneration Disc Intervertebral, miRNA
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, excised and Diagnostic work up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2025to 12 Oct 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ıvdd surgery, fracture suregery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, Çanakkale, 17100
About this study
Aim of the Study:
The aim of this study is to determine the expression levels of candidate microRNAs (miRNAs) expressed in human degenerated intervertebral disc tissues. In line with this objective, our specific goals are outlined below:
Read more
Objectives:
Objective 1:
To include patients diagnosed with lumbar disc herniation (LDH) who are scheduled for lumbar microdiscectomy (LMD), and patients diagnosed with vertebral fractures who are scheduled for decompression or fusion surgeries, by obtaining informed consent in accordance with ethical standards.
Objective 2:
To collect degenerated intervertebral disc tissues obtained during LMD or spinal cord repair surgeries into cryotubes in duplicates for real-time PCR (rt-PCR) analysis, and to store them under appropriate conditions until analysis.
Objective 3:
To identify candidate miRNAs that regulate genes associated with the pathophysiology of intervertebral disc degeneration (IVDD) using databases such as miRBase, miRTar, and miRDB.
Objective 4:
To determine the expression levels of candidate miRNAs associated with nucleus pulposus cell proliferation in human degenerated disc tissues.
Objective 5:
To determine the expression levels of candidate miRNAs associated with apoptosis of nucleus pulposus cells in human degenerated disc tissues.
Objective 6:
To determine the expression levels of candidate miRNAs associated with extracellular matrix (ECM) remodeling in human degenerated disc tissues.
Objective 7:
To determine the expression levels of candidate miRNAs associated with cartilaginous endplate dysfunction in human degenerated disc tissues.
Objective 8:
To determine the expression levels of candidate miRNAs associated with annulus fibrosus degeneration in human degenerated disc tissues.
Objective 9:
To determine the expression levels of candidate miRNAs associated with inflammatory processes in human degenerated disc tissues.
Objective 10:
To compare the expression levels of each candidate miRNA identified in degenerated disc tissues with those found in non-degenerated disc tissues obtained during spinal cord repair surgeries.
- Conditions
- Degeneration Disc Intervertebral, miRNA
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, excised, Diagnostic work up
- Keywords
- Disc degeneration, miRNA
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesDiagnostic test
During surgery, degenerated intervertebral disc tissues will be collected under sterile conditions and stored at -80°C in cryotubes. miRNA expression profiles will be analyzed using rt-PCR. Candidate miRNAs are selected based on databases such as miRBase, miRTar, and miRDB.
excisedDiagnostic test
Intervertebral disc tissues that are not degenerated will be collected during surgery and stored in the same manner as in the IVDD group. These samples will be used for comparative analysis of miRNA expression via rt-PCR to serve as the control baseline.
Diagnostic work upDiagnostic test
During surgery, degenerated intervertebral disc tissues will be collected under sterile conditions and stored at -80°C in cryotubes. miRNA expression profiles will be analyzed using rt-PCR. Candidate miRNAs are selected based on databases such as miRBase, miRTar, and miRDB.
| Study group | Role | What they receive |
|---|---|---|
| Degenerated Disc Group (IVDD Group) | Experimental | This group consists of patients diagnosed with lumbar disc herniation (LDH) who are scheduled for lumbar microdiscectomy (LMD) surgery due to intervertebral disc degeneration (IVDD). Receives: Diagnostic Test: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines; Diagnostic Test: excised; Diagnostic Test: Diagnostic work up |
| Non-degenerated Disc Control Group | Experimental | This group includes patients undergoing spinal surgery (decompression or fusion) due to vertebral fractures, with no signs of intervertebral disc degeneration. Only patients without degenerative changes on imaging will be included. Receives: Diagnostic Test: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines; Diagnostic Test: excised; Diagnostic Test: Diagnostic work up |
What is being measured
The primary outcome is the main question the study is designed to answer.
disc degeneration
degeneration level assessment
Measured: 1 year
Secondary outcomes (1)
disc degeneration
degeneration level assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Apr 2025
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration Disc IntervertebralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Collaborators
- Canakkale 18 Mart University Health Research and Application Hospital
- Responsible party
- Principal investigator, DAMLA AYKORA, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114497
- Sponsor's protocol ID
- TSA-2025-5076
- Other IDs
- TSA-2025-5076
- Acronym
- MIRADISC
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues
- ClinicalTrials.gov ID
- NCT07114497
- Acronym / sponsor ID
- MIRADISC / TSA-2025-5076
- Conditions
- Degeneration Disc Intervertebral, miRNA
- Keywords
- Disc degeneration, miRNA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Collaborators
- Canakkale 18 Mart University Health Research and Application Hospital
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
Aim of the Study:
The aim of this study is to determine the expression levels of candidate microRNAs (miRNAs) expressed in human degenerated intervertebral disc tissues. In line with this objective, our specific goals are outlined below:
Objectives:
Objective 1:
To include patients diagnosed with lumbar disc herniation (LDH) who are scheduled for lumbar microdiscectomy (LMD), and patients diagnosed with vertebral fractures who are scheduled for decompression or fusion surgeries, by obtaining informed consent in accordance with ethical standards.
Objective 2:
To collect degenerated intervertebral disc tissues obtained during LMD or spinal cord repair surgeries into cryotubes in duplicates for real-time PCR (rt-PCR) analysis, and to store them under appropriate conditions until analysis.
Objective 3:
To identify candidate miRNAs that regulate genes associated with the pathophysiology of intervertebral disc degeneration (IVDD) using databases such as miRBase, miRTar, and miRDB.
Objective 4:
To determine the expression levels of candidate miRNAs associated with nucleus pulposus cell proliferation in human degenerated disc tissues.
Objective 5:
To determine the expression levels of candidate miRNAs associated with apoptosis of nucleus pulposus cells in human degenerated disc tissues.
Objective 6:
To determine the expression levels of candidate miRNAs associated with extracellular matrix (ECM) remodeling in human degenerated disc tissues.
Objective 7:
To determine the expression levels of candidate miRNAs associated with cartilaginous endplate dysfunction in human degenerated disc tissues.
Objective 8:
To determine the expression levels of candidate miRNAs associated with annulus fibrosus degeneration in human degenerated disc tissues.
Objective 9:
To determine the expression levels of candidate miRNAs associated with inflammatory processes in human degenerated disc tissues.
Objective 10:
To compare the expression levels of each candidate miRNA identified in degenerated disc tissues with those found in non-degenerated disc tissues obtained during spinal cord repair surgeries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degenerated Disc Group (IVDD Group) | Experimental | Diagnostic Test: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Diagnostic Test: excised, Diagnostic Test: Diagnostic work upThis group consists of patients diagnosed with lumbar disc herniation (LDH) who are scheduled for lumbar microdiscectomy (LMD) surgery due to intervertebral disc degeneration (IVDD). |
| Non-degenerated Disc Control Group | Experimental | Diagnostic Test: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Diagnostic Test: excised, Diagnostic Test: Diagnostic work upThis group includes patients undergoing spinal surgery (decompression or fusion) due to vertebral fractures, with no signs of intervertebral disc degeneration. Only patients without degenerative changes on imaging will be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ıvdd surgery, fracture suregery
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesDuring surgery, degenerated intervertebral disc tissues will be collected under sterile conditions and stored at -80°C in cryotubes. miRNA expression profiles will be analyzed using rt-PCR. Candidate miRNAs are selected based on databases such as miRBase, miRTar, and miRDB. | Diagnostic test | Degenerated Disc Group (IVDD Group), Non-degenerated Disc Control Group |
| excisedIntervertebral disc tissues that are not degenerated will be collected during surgery and stored in the same manner as in the IVDD group. These samples will be used for comparative analysis of miRNA expression via rt-PCR to serve as the control baseline. | Diagnostic test | Degenerated Disc Group (IVDD Group), Non-degenerated Disc Control Group |
| Diagnostic work upDuring surgery, degenerated intervertebral disc tissues will be collected under sterile conditions and stored at -80°C in cryotubes. miRNA expression profiles will be analyzed using rt-PCR. Candidate miRNAs are selected based on databases such as miRBase, miRTar, and miRDB. | Diagnostic test | Degenerated Disc Group (IVDD Group), Non-degenerated Disc Control Group |
Primary outcome
disc degeneration
Time frame: 1 year
degeneration level assessment
1 secondary outcome
disc degeneration
Time frame: 1 year
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 11 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, excised and Diagnostic work up in people with Degeneration Disc Intervertebral and miRNA, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. 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 Turkey (Türkiye). 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?
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?
disc degeneration (time frame: 1 year). 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 11 Aug 2025.