| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
|
|
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. |