Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues

NCT07114497 | Active Not Recruiting

• 1 other identifier: TSA-2025-5076
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Degeneration Disc Intervertebral; miRNA

Keywords

Disc degeneration; miRNA

Outcome Measures

Primary Outcomes (1)

• disc degeneration

  degeneration level assessment

  1 year

Secondary Outcomes (1)

• disc degeneration

  1 year

Study Arms (2)

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).

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.

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

Interventions

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.

Degenerated Disc Group (IVDD Group); Non-degenerated Disc Control Group

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.

Degenerated Disc Group (IVDD Group); Non-degenerated Disc Control Group

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.

Degenerated Disc Group (IVDD Group); Non-degenerated Disc Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ıvdd surgery, fracture suregery

You may not qualify if:

• none

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead
• Canakkale 18 Mart University Health Research and Application Hospital: collaborator

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 11, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)