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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

Validation of breast cancer and cardiovascular disease (CVD) risk prediction services in India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094544
Enrollment
900
Registered
2025-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: I998- Other disorder of circulatory system

Interventions

Intervention1: Nil: Nil

Sponsors

NALAGENETICS PTE LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Sample collections Genotyping risk prediction analysis and return of results to Nala WGS and risk prediction analysis on the same samples

Secondary

MeasureTime frame
NILTimepoint:

Countries

India

Contacts

Public ContactDr Vinoth Kumar Lakshmanan

Sri Ramachandra Institute of Higher education and Research

vinoth.lakshmanan@sriramachandra.edu.in8072052909

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026