| CTRI Number |
CTRI/2024/05/067320 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of pattern and effects of viruses in hemato-lymphoid malignancies among children |
|
Scientific Title of Study
|
Epidemiological spectrum of viromes among pediatric population with hemato-lymphoid malignancies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwin Sarang S |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.39,Pathology block,Department of Microbiology,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7338889001 |
| Fax |
|
| Email |
ashwinsarang17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.41,Pathology block,Department of Microbiology,Maulana Azad Medical college
Central
DELHI
110002
India |
| Phone |
9968604387 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.41,Pathology block,Department of Microbiology,Maulana Azad Medical college
Central
DELHI
110002
India |
| Phone |
9968604387 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
2,Bahadurshah Zafar Marg,New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
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 Ashwin Sarang S |
Maulana Azad Medical College |
Room no.41 ,Pathology block,Department of Microbiology,Maulana Azad Medical College
Central
DELHI |
7338889001
ashwinsarang17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 12 years
Children whose bone marrow and lymph node biopsy/aspirate are done as a part of routine diagnostic procedure |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Viromes in children diagnosed with hemato-lymphoid malignancies is identified |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The association between the presence of viromes to that of virus specific antibody for Epstein Barr Virus,Parvovirus B19,Cytomegalovirus,Hepatitis B,Hepatitis C and Varicella Zoster Virus in the children will be obtained |
1 year |
| The utility of the peripheral blood for identification of viromes when compared with invasive specimen(BM/LN biopsy/aspirate)is known. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/06/2024 |
| 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
|
The study entitled"Epidemiological spectrum of viromes among pediatric population with hemato-lymphoid malignancies" will be conducted at Dept.of Microbiology,Maulana Azad Medical College,in collaboration with Department of Pediatric Medicine and Pathology,Maulana Azad Medical College.Only after proper consent bone marrow aspirate,lymph node aspirate/biopsy,biopsy,blood,saliva,urine will be taken for RT-PCR as a part of diagnosis.Further,on isolation of virus from any suspected cases,it will be subjected to "Next Generation Sequencing" of the virus.This study will be beneficial for the patients in establishing microbiological diagnosis of the disease. |