Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues
NCT ID: NCT07114497
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-04-11
2026-10-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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Degenerated Disc Group (IVDD Group)
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).
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
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.
excised
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 up
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.
Non-degenerated Disc Control Group
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.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
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.
excised
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 up
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.
Interventions
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surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
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.
excised
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 up
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Canakkale 18 Mart University Health Research and Application Hospital
UNKNOWN
Çanakkale Onsekiz Mart University
OTHER
Responsible Party
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DAMLA AYKORA
Principal Investigator
Locations
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Çanakkale Onsekiz Mart University
Çanakkale, Çanakkale, Turkey (Türkiye)
Countries
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Other Identifiers
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TSA-2025-5076
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TSA-2025-5076
Identifier Type: -
Identifier Source: org_study_id
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