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CTRI Number  CTRI/2022/09/045295 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 02/08/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Assessment of Breast cancer risk factors and developing risk prediction model.  
Scientific Title of Study   Assessment of Breast cancer risk profile and factors implicit in differential incidence rates within rural and urban populations in India by developing a machine learning-based risk prediction tool. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jitendra Kumar Meena 
Designation  Assistant Professor  
Affiliation  AIIMS, New Delhi 
Address  Dept. of Preventive Oncology National Cancer Institute (NCI), Jhajjar (AIIMS), Vill. Badsa

Jhajjar
HARYANA
124105
India 
Phone  9899554396  
Fax    
Email  drmeenajk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitendra Kumar Meena 
Designation  Assistant Professor  
Affiliation  AIIMS, New Delhi 
Address  Dept. of Preventive Oncology National Cancer Institute (NCI), Jhajjar (AIIMS), Vill. Badsa

Jhajjar
HARYANA
124105
India 
Phone  9899554396  
Fax    
Email  drmeenajk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitendra Kumar Meena 
Designation  Assistant Professor  
Affiliation  AIIMS, New Delhi 
Address  Dept. of Preventive Oncology National Cancer Institute (NCI), Jhajjar (AIIMS), Vill. Badsa

Jhajjar
HARYANA
124105
India 
Phone  9899554396  
Fax    
Email  drmeenajk@gmail.com  
 
Source of Monetary or Material Support  
Division of Biomedical Informatics (BMI) Indian Council of Medical Research (ICMR),Ansari Nagar, New Delhi - 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  Division of Biomedical Informatics (BMI) Indian Council of Medical Research (ICMR), Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
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 Jitendra Kumar Meena   National Cancer Institute (NCI), Jhajjar   Dept. of Preventive Oncology National Cancer Institute (NCI), Jhajjar (AIIMS), Vill. Badsa, Pin: 124105
Jhajjar
HARYANA 
9899554396

drmeenajk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy community based female residents  
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Cases:
a) Histopathological confirmation of breast cancer
b) Primary breast cancer disease
c) New registration at the study site (NCI, Jhajjar)
2. Controls:
a) Screen negative on clinical breast examination
b) No history of breast cancer or other malignancy
 
 
ExclusionCriteria 
Details  1. Cases:
a) Histopathological no non-confirmation of breast cancer
b) Benign breast disease
c) Secondary or metastatic breast cancer disease
d) Non consent for participation
2. Controls:
a) Non-consent for participation or undergoing confirmatory testing (suspects).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of possible risk factors and their association with Breast cancer.  Single 
 
Secondary Outcome  
Outcome  TimePoints 
Evolution of a risk calculation model based on the above risk factors using machine learning.

 
2-3 year 
Rural and Urban Cohort risk monitoring and screening for Breast cancer  1-2 year 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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)   01/11/2022 
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="3"
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  

Background: GLOBOCAN data suggest that breast cancer has the highest burden in Indian women with an age-adjusted incidence (25.8) and death (12.7) per 100,000 women rate which is slated to rise further. The rising burden of breast cancer is unabated due to the lack of population risk data, awareness, targeted interventions, late detection, and management. To the best of our knowledge, this is the first attempt at developing a risk prediction tool for Breast cancer in India. There is a glaring need to explore modifiable Breast cancer risk factors in India with an intent to educate the public to enhance risk awareness, screening uptake, risk reduction, early detection, and improved clinical outcomes. Objectives: The study aims the identification of possible risk factors for Breast cancer and variables affecting differential cancer incidence in rural and urban populations in India. The development of a machine learning-based risk prediction tool will help in continuous data integration for accurate Breast cancer risk profile assessment and can be expanded for uses across India. Methods: A matched case-control study will be done where cases will be enrolled from those getting registered at National Cancer Institute (NCI) and controls will be selected from preidentified urban and rural community cohorts. The project will be implemented in two phases where initial data i.e. socio-demographic, personal, environmental, clinical profile, laboratory, etc. of those with (cases, N= 500) and without breast cancer (controls, N= 1000) will be collected. In the next phase, a tool would be developed and internally validated for the identification of significant risk factors using a machine learning tool. Subsequently, as a future direction, the tool will be integrated into an open IT (webpage, m-health app) platform for application in a real-world field setting for application in community cohorts for risk surveillance and external validation. Expected outcome: The study will assess the prevalence of possible risk factors and their association with Breast cancer. Additionally, the Identification of socio-epidemiological factors linked to differential incidence rates of breast cancer in urban and rural populations in India by developing a UI (user interface) risk calculation model embedding continuous data integration process into machine learning algorithms for improved accuracy. 

 
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