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CTRI Number  CTRI/2024/08/072861 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   DNA variation between ancestries 
Scientific Title of Study   Harnessing DNA methylation variation between populations to understand disease discordance across ancestries. 
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 Sharayu Mhatre 
Designation  Scientific Officer E 
Affiliation  Centre for Cancer Epidemiology, Tata Memorial Centre 
Address  Room no-123, 1st floor, Division of Molecular Epidemiology and Population Genetics, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Center for cancer epidemiology Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9137792085  
Fax    
Email  mhatresharayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharayu Mhatre 
Designation  Scientific Officer E 
Affiliation  Centre for Cancer Epidemiology, Tata Memorial Centre 
Address  Room no-123, 1st floor, Division of Molecular Epidemiology and Population Genetics, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Center for cancer epidemiology Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9137792085  
Fax    
Email  mhatresharayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharayu Mhatre 
Designation  Scientific Officer E 
Affiliation  Centre for Cancer Epidemiology, Tata Memorial Centre 
Address  Room no-123, 1st floor, Division of Molecular Epidemiology and Population Genetics, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Center for cancer epidemiology Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9137792085  
Fax    
Email  mhatresharayu@gmail.com  
 
Source of Monetary or Material Support  
Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Tata Memorial Centre Kharghar, Navi Mumbai, Maharashtra 410210  
 
Primary Sponsor  
Name  Medical Research Council UK 
Address  Research and Enterprise Division, University of Bristol, Augustine Courtyard Orchard Lane, Bristol, England, UK, Postcode BS1 5DS  
Type of Sponsor  Research institution 
 
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 Sharayu Mhatre  Centre for Cancer Epidemiology, Kharghar  Room no-123, 1st floor, Division of Molecular Epidemiology and Population Genetics, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 
9137792085

mhatresharayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial center, TMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1.Male or Female who participated in the previous study (Project No.3114) 2.Age: 20-70 (at the time of the enrolment of Project no.3114) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male or Female who participated in the previous study (Project No.3114)
2.Age: 20-70 (at the time of the enrolment of Project no.3114)
 
 
ExclusionCriteria 
Details  1. Unwilling to participate
2. Has a history of cough, cold, and fever
3. Unable to lie still
4. Unable to hold breath voluntarily or hear instructions
5. Unable to complete the process because of physical disabilities.
6. Pregnant women /lactating women
7. Had surgery in the last 6 weeks
8. Had a scan or x-ray in the last 2 weeks which involved taking a contrast medium 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pre-study power calculations to detect cis and trans mQTLs in 13,278 participants showed that we will have 80% power to detect a cis mQTL at a p-val threshold of 1e-8 with rsq is equal to 0.003.
We have included a robust and reproducible federated analysis approach. We will develop a github pipeline where collaborators will download a suite of scripts and run the analyses in their cohort.
1.mQTL analyses
2.EWAS analyses
3.Replication
4.MR analyses  
Total 1 year of the project, consist of 6 months of laboratory execution and 6 months of data analysis

 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2024 
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)   Open to Recruitment 
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  

DNA methylation (DNAm) plays a central role in gene regulation. It helps to define how cells respond to genetic and environmental signals and, ultimately, contributes to the whole system’s health and disease status. Levels of DNAm differ from one person to another. Some of these variation in DNAm levels is caused by genetic or environmental factors. Understanding the variation in DNAm levels will helps us to understand that why the disease risk and response to treatment is different for different population. Evaluating DNAm variation in diverse population groups allows comparison across varying genetic and environmental exposure profiles.

This will allow the identification of molecular mechanisms that underpin difference in disease prevalence across the global population. Aim is to map genetic and environmental determinants of human DNAm variation to understand mechanisms of DNAm variability. We will generate a catalogue of genetic associations with DNAm across populations worldwide.  This will help us to understand functional role of genetic variability in descending disease risk.

The second aim of the project is to understand mechanisms of disease and differences in disease and risk in different population. This research builds a global partnership of teams to bring together genetic and epigenetic data collected from individuals worldwide. A key aspect of this proposal is building equitable partnerships between these teams. This is essential in order to build capacity for research in genetically diverse datasets.

Identification of common and context-specific mechanisms of health and disease mediated by DNAm is of high health impact because it will enable actions to reduce global health disparity and inequity via targeted interventions or treatments.

 
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