Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues

Not Applicable

Active, not recruiting

• Conditions: Degeneration Disc Intervertebral; miRNA

• Registration Number: NCT07114497
• Lead Sponsor: Çanakkale Onsekiz Mart University

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-11
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-10-12
• Study Completion: 2026-10-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ıvdd surgery, fracture suregery

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
disc degeneration	1 year	degeneration level assessment

Secondary Outcome Measures

Name	Time	Method
disc degeneration	1 year	degeneration level assessment

Trial Locations

Locations (1)

Çanakkale Onsekiz Mart University; 🇹🇷 Çanakkale, Turkey