| 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
|
|
|
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
|
|
|
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
|
|
|
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. |