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