| CTRI Number |
CTRI/2024/10/075106 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Research on microRNA 21 levels in blood cancer |
|
Scientific Title of Study
|
A study on expression of microRNA 21 in chronic lympho-proliferative disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Yadav |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of Medicine ,Maulana Azad Medical College and associated hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8168331738 |
| Fax |
|
| Email |
Rahulyadavboy1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Aggarwal |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical college |
| Address |
BL Taneja Block ,Department of Medicine, Maulana Azad Medical College and associated hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968281414 |
| Fax |
|
| Email |
drsunita.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Yadav |
| Designation |
Post graduate Resident |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of Medicine ,Maulana Azad Medical College and associated hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8168331738 |
| Fax |
|
| Email |
Rahulyadavboy1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Rahul Yadav |
Lok Nayak Hospital |
Ward 32 , 4th floor , New Medical Block, Department of Medicine, Lok Nayak Hospital, New Delhi
New Delhi
DELHI |
8168331738
Rahulyadavboy1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 12 year who are newly diagnosed cases of chronic lympho-proliferative disorders.
2.Patients willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with acute leukemia.
2.Patients with chronic myeloproliferative neoplasm. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| expression of microRNA 21 in chronic lympho-proliferative disorders. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of microRNA 21 with clinical staging of lympho-proliferative disorders. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
21/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic lymphoproliferative disorder comprise a heterogeneous group of diseases characterized by uncontrolled production of lymphocytes that cause monoclonal lymphocytosis, lymphadenopathy and bone marrow infiltration. Chronic lymphoproliferative disorder are tumor of mature lymphocytes. Micro RNA are endogenous non coding single stranded RNA miRNA orchestrate various cellular functions and play critical roles in many biologic processes, including cell differentiation, apoptosis, proliferation and cancer development. This study aims to analyse microRNA 21 levels in different chronic lympho-proliferative disorders and correlating microRNA 21 levels with clinical stage of chronic lympho-proliferative disorder. The purpose of study is to analyse microRNA 21 levels in different lymphoproliferative disorders and as diagnostic marker and as a future cancer biomarker. |