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CTRI Number  CTRI/2021/04/032570 [Registered on: 06/04/2021] Trial Registered Prospectively
Last Modified On: 21/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   The role of serum microRNAs and inflammatory mediators in intervertebral disc degeneration and their value as biomarkers  
Scientific Title of Study   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) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janardhana Aithala P 
Designation  Professor and Unit Head 
Affiliation  Yenepoya Medical College, Mangalore 
Address  Department of Orthopedics, Yenepoya Medical College, Deralakatte, Mangalore
Yenepoya Medical College, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448623745  
Fax    
Email  janardanaaithala@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant Kumar Modi 
Designation  Senior Scientific Officer 
Affiliation  Yenepoya Research centre Mangalore 
Address  Yenepoya Research centre, 3rd floor, Academic block, Yenepoya University (Deemed to be), Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9873662911  
Fax    
Email  prashantmodi@yenepoya.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prashant Kumar Modi 
Designation  Senior Scientific Officer 
Affiliation  Yenepoya Research centre Mangalore 
Address  Yenepoya Research centre, Yenepoya University (Deemed to be), Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9873662911  
Fax    
Email  prashantmodi@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Seed grant, Yenepoya University (Deemed to be) Yenepoya medical college Hospital, Deralakatte, Mangalore 
 
Primary Sponsor  
Name  Yenepoya University Deemed to be 
Address  Yenepoya University (Deemed to be), Deralakatte, Mangalore 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Janardhana Aithala P  Yenepoya Medical College Hospital  Yenepoya medical College, Deralakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA 
9448623745

janardanaaithala@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics committee 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. List of miRNAs and serum proteins from disc material and blood.
2. Correlation of these miRNA and serum proteins between different age groups, and different grades of disc degeneration.  
0 (Baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
Validation of miRNA and serum biomarkers using literature.   0-2 years 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study not started, hence not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The current literatures available only focused on the finding specific miRNAs and the etermination of the role of the specific miRNAs in the disk degeneration. The ultimate goal in 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 majority of the papers. The investigation into the circulating miRNAs are not widely conducted and there is a lack of reports regarding this topic. There is also no study that correlates miRNAs from disk with serum miRNAs. The, establishment of a miRNA expression profile and inflammatory markers in serum is important for investigating the underlying functional mechanisms for IDD, and a better knowledge of their expression patterns could reveal molecular signatures that can be developed as therapeutic and diagnostic targets as well. There is also the problem that the miRNAs are multifunctional. They not only regulate IDD but also inflammatory responses, cancer and so on. Hence, it is imperative that we find multiple specific miRNAs and the relationship between inflammatory mediators and grade of degradation in order to develop biomarker for the early detection of IDD.

In this proposed study, we wish to identify altered signature of miRNAs and inflammatory markers during the progression of IDD at different clinical stages as evidence by MRI by using RNA sequencing technique, qRTPCR and ELISA. We will also performed Mass spectrometry based serum proteomics profile of these subjects. Lastly we will correlate between disease severity, miRNA expression and altered proteins between healthy control and IDD subjects. This will lead to identification of IDD stage specific molecular signature which may help in early diagnosis or prediction of the disease and may helpful in selection of treatment strategies. The early detection also helps in successive treatments as the longer the disease is untreated, the worse is the outcome.

 
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