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NCT Number: NCT07114497

Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çanakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ıvdd surgery, fracture suregery

Exclusion criteria

  • none

Treatment and study plan

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Diagnostic 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.

excised

Diagnostic 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 up

Diagnostic 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.

Primary outcomes

  1. disc degeneration

    Time frame: 1 year

    degeneration level assessment

Secondary outcomes

  1. disc degeneration

    Time frame: 1 year

    degeneration level assessment

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Collaborators

  • Canakkale 18 Mart University Health Research and Application Hospital

Registry information

Acronym: MIRADISC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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