跳至主要内容
临床试验/CTRI/2021/04/032570
CTRI/2021/04/032570尚未招募不适用

The role of serum microRNAs and inflammatory mediators in intervertebral disc degeneration (IDD) and their value as biomarkers for early detection of intervertebral disk degeneration (IDD)

Yenepoya University Deemed to be1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
168
试验地点
1
主要终点
1. List of miRNAs and serum proteins from disc material and blood.

研究概览

简要总结

The current literatures available only focusedon the finding specific miRNAs and the etermination of the role of the specific miRNAs in the disk degeneration. The ultimate goalin each study was to find novel diagnostic or therapeutic agent for the treatment of IDD.The potential of miRNAs as bio markers was not discussed in majorityof the papers. The investigation into the circulating miRNAs are not widely conducted and thereis a lack of reports regarding this topic. Thereis also no study that correlates miRNAs from disk with serum miRNAs. The, establishment of a miRNA expression profileand inflammatory markers in serum is important for investigating the underlyingfunctional mechanisms for IDD, and a better knowledgeof their expression patternscould reveal molecular signatures that can be developedas therapeutic and diagnostictargets as well. There is also the problem that the miRNAs are multifunctional. They not only regulate IDD but also inflammatoryresponses, cancer and so on. Hence, it isimperative that we find multiple specific miRNAs and the relationship betweeninflammatory mediatorsand grade of degradation in order to develop biomarker for the early detection ofIDD.

In this proposedstudy, we wish to identifyaltered signatureof miRNAs and inflammatory markersduring the progression of IDD at differentclinical stagesas evidence by MRI by using RNA sequencing technique, qRTPCR and ELISA. We willalso performed Mass spectrometry based serum proteomics profileof these subjects. Lastly we will correlate between diseaseseverity, miRNA expression and altered proteins between healthy control and IDD subjects. This will lead to identification of IDD stagespecific molecular signature which may help in early diagnosisor prediction of the disease and may helpful in selection of treatment strategies. The early detection also helps in successivetreatments as the longer the disease is untreated, the worse isthe outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All patients with low backache and who have undergone MRI for the evaluation of backache, which confirms the presence of disc degeneration of the lumbar spine.

排除标准

  • Patients with a history of previous trauma or infections to the spine.
  • Diabetes mellitus, patients with inflammatory arthritis.
  • Patients who have undergone previous surgery.
  • Patients who have major deformities like scoliosis and kyphosis.

结局指标

主要结局

1. List of miRNAs and serum proteins from disc material and blood.

时间窗: 0 (Baseline)

2. Correlation of these miRNA and serum proteins between different age groups, and different grades of disc degeneration.

时间窗: 0 (Baseline)

次要结局

  • Validation of miRNA and serum biomarkers using literature.(0-2 years)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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