| CTRI Number |
CTRI/2025/09/094544 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Nala MammoReady and Nala CardiacReady are capable of identifying elevated risk among cases in comparison to controls for study participants to enhance the screening initiatives |
|
Scientific Title of Study
|
Validation of breast cancer and cardiovascular disease (CVD) risk prediction services in India |
| 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 Vinoth Kumar Lakshmanan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai.
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8072052909 |
| Fax |
04424767008 |
| Email |
vinoth.lakshmanan@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinoth Kumar Lakshmanan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8072052909 |
| Fax |
04424767008 |
| Email |
vinoth.lakshmanan@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinoth Kumar Lakshmanan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai
Room No-01
Faculty of Clinical Research
Sri Ramachandra Institute of Higher Education and research
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8072052909 |
| Fax |
04424767008 |
| Email |
vinoth.lakshmanan@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical Centre
Sri Ramachandra Medical College and Research Institute,
No.1 Ramachandra Nagar Porur,
Chennai - 600 116
Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
NALAGENETICS PTE LTD |
| Address |
Lower Delta Road, #04-06/08
Singapore 169204 |
| Type of Sponsor |
Other [Biotechnology company] |
|
|
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 Vinoth Kumar Lakshmanan |
Sri Ramachandra Institute of Higher education and Research |
1st Floor, Block A1, Department of Cardiology and C0 and C1 blocks,
Department of Radiology and Imaging sciences
Chennai
TAMIL NADU |
8072052909
vinoth.lakshmanan@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Females without Breast cancer and no prior diagnosis of CAD related Cardiovascular disorders. |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Validation of MammoReadyTM
Inclusion criteria for the control group:
Females with age ranging from 35 to 75 years old.
Had never ever been diagnosed with breast cancer.
Did not experience any symptoms related to breast cancer.
Without first degree relationship with breast cancer case.
Without family history of Ovarian cancer.
Inclusion criteria for the case group
Females with age ranging from 35 to 70 years old.
Had ever been diagnosed with breast cancer.
With or without first degree relationship with breast cancer case.
With or without family history of ovarian cancer.
Validation of CardiacReadyTM
Inclusion criteria for the control group
Age ranging from 40 to 70 years old.
No prior diagnosis or family history of CAD related cardiovascular disorder but not limited to hypertension, diabetes, myocardial infarction, stroke, angina pectoris, arrhythmia, chronic kidney disease, peripheral artery disease.
Inclusion criteria for the case group.
Age ranging from 40 to 70 years old.
Ever diagnosed with acute myocardial infarction and or subsequent myocardial infarction. |
|
| ExclusionCriteria |
| Details |
Validation of MammoReadyTM
Exclusion criteria for the control group:
Individuals who cannot give informed consent (e.g. due to cognitive impairment);
Patients with known other serious illness that might interfere with their ability to participate in the study;
Patients who are not willing to undergo genetic testing or unable to provide saliva sample;
Females aged younger than 35 or older than 75 years old;
Woman with known history of any cancer;
Woman with prior diagnosis of non-cancerous breast conditions (fibroadenomas, fibrosis and simple cysts);
Woman who has undergone a radiation on chest area;
Woman who has undergone breast biopsy;
Woman who has undergone any surgery (augmentation or prophylactic).
Exclusion criteria for the case group:
Individuals who cannot give informed consent (e.g. due to cognitive impairment);
Patients with known other serious illness that might interfere with their ability to participate in the study;
Patients who are not willing to undergo genetic testing or unable to provide saliva sample;
Females aged younger than 35 or older than 75;
Patients who are not clinically diagnosed with breast cancer.
Validation of CardiacReadyTM
Exclusion criteria for the control group:
Individuals who cannot give informed consent (e.g. due to cognitive impairment);
Patients with known other serious illness that might interfere with their ability to participate in the study;
Patients who are not willing to undergo genetic testing or unable to provide saliva sample;
Patients with known other forms of heart disease including but not limited to congenital heart disease, valvular heart disease, cardiomyopathy, etc, which could confound relationship between the polygenic risk score and myocardial infarction;
Female patient in pregnancy;
Patients with a history of documented CAD-related disorders.
Exclusion criteria for the case group:
Individuals who cannot give informed consent (e.g. due to cognitive impairment);
Patients with known other serious illness that might interfere with their ability to participate in the study;
Patients who are not willing to undergo genetic testing or unable to provide saliva sample;
Patients with known other forms of heart disease including but not limited to congenital heart disease, valvular heart disease, cardiomyopathy, etc, which could confound relationship between the polygenic risk score and myocardial infarction;
Female patient in pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
With MammoReady polygenic risk scores (PRS) which evaluate the cumulative effect of various genetic variants throughout the genome on an individuals likelihood of developing breast cancer.
With CardiacReady™ we have the potential to significantly improve screening initiatives in India by merging genetic data with conventional risk factors. |
Sample collections Genotyping risk prediction analysis and return of results to Nala
WGS and risk prediction analysis on the same samples |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="900"
Sample Size from India="900"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| 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 Yet Recruiting |
| 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
|
Breast cancer represents a major health issue in India constituting 14 percentage of cancers among Indian women A report from 2018 on breast cancer statistics indicated that there were 162468 newly registered cases and 87090 reported fatalities The low survival rate for breast cancer among women in India can be linked to factors such as insufficient awareness and inadequate rates of early screening and diagnosis Current breast cancer screening tests in India mainly focus on monogenic factors particularly BRCA1 and BRCA2 mutations nevertheless these screening techniques do not include polygenic risk scores PRS which evaluate the cumulative effect of various genetic variants throughout the genome on an individuals likelihood of developing breast cancer although PRS testing is becoming more popular it currently lacks comprehensive and clinically validated solutions for instance allelica provides software while illuminas infinum global diversity array is oriented towards research
Cardiovascular disease CVD stands as the primary cause of death in India in 2017 CVD accounted for 26.6 percentage of all fatalities and 13.6 percentage of total disability adjusted life years DALYs the India state level disease burden study conducted by the global burden of disease GBD group revealed a 2.3 fold increase in the incidence of ischemic heart disease IHD and stroke from 1990 to 2016 furthermore the number of CVD cases more than doubled during this timeframe resulting from 25.7 million in 1990 to 54.5 million in 2016 in India CVD screening employs various methods including blood pressure measurements blood glucose testing and lipid profiling to evaluate clinical risk factors such as hypertension diabetes and elevated cholesterol levels techniques like electrocardiograms ECG stress testing and echocardiography are commonly utilized in clinical environments to identify heart irregularities community oriented initiatives such as the national programme for prevention and control of cancer diabetes cardiovascular disease and stroke NPCDCS organize health camps aimed at early detection particularly in rural regions with cardiac ready tm we have the potential to significantly improve screening initiatives in India by merging genetic data with conventional risk factors |