Investigation of miRNA Expression Profiles in Human Degenerated Intervertebral Disc Tissues (MIRADISC)

Çanakkale Onsekiz Mart University

Status: Active, not recruiting

Conditions: miRNA; Degeneration Disc Intervertebral

Treatments: Diagnostic Test: Diagnostic work up; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07114497

TSA-2025-5076 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ıvdd surgery, fracture suregery

Exclusion criteria

• none

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Degenerated Disc Group (IVDD Group)

Experimental group

Description:

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).

Treatment:

Diagnostic Test: excised

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

Diagnostic Test: Diagnostic work up

Non-degenerated Disc Control Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: excised

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

Diagnostic Test: Diagnostic work up