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CTRI Number  CTRI/2018/06/014362 [Registered on: 01/06/2018] Trial Registered Prospectively
Last Modified On: 30/05/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Breast cancer risk assessment model for Indian women 
Scientific Title of Study   Development of Breast cancer risk assessment model for Indian women: A case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suhani 
Designation  Assistant Professor 
Affiliation  All India Instittute of Medical Sciences 
Address  Department of Surgical Disciplines, Room number 5025, Fifth floor, Teaching Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Ansari Nagar (East), New Delhi
South
DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suhani 
Designation  Assistant Professor 
Affiliation  All India Instittute of Medical Sciences 
Address  Department of Surgical Disciplines, Room number 5025, Fifth floor, Teaching Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Ansari Nagar (East), New Delhi

DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Suhani 
Designation  Assistant Professor 
Affiliation  All India Instittute of Medical Sciences 
Address  Department of Surgical Disciplines, Room number 5025, Fifth floor, Teaching Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Ansari Nagar (East), New Delhi

DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, New Delhi 
 
Primary Sponsor  
Name  AIIMS Delhi  
Address  All India Institute of medical sciences, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Suhani  All India Institute of Medical Sciences, New Delhi  Room number 5025, Department of Surgical Disciplines Fifth floor, Teaching block Ansari Nagar (East) New Delhi
South
DELHI 
9810534358

drsuhani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breast cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Women with biopsy-proven breast cancer, as cases;
Women >18 years of age not having personnal history of cancer, as controls;
Women willing to participate in the study
 
 
ExclusionCriteria 
Details  Women who are not willing to participate in the study;
Women having known malignancies other than breast carcinoma;
For control group: woman with personnal history of cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To develop an breast cancer risk assessment model applicable to Indian women, as feasible.

2.To validate the above breast cancer risk assessment model prospectively.
 

Duration of study: from start of study till data collection and analysis , approximately 3 years. however no follow up shall be done as part of this study 
 
Secondary Outcome  
Outcome  TimePoints 
To study the clinico-epidemiologic and reproductive risk factors for breast cancer in Indian woman.


 
Duration of study: from start of study till data collection and analysis , approximately 3 years. however no follow up shall be done as part of this study 
To evaluate the clinical applicability of Gail model 2 (GM2) as a means of estimating 5 year and lifetime risk of breast cancer in Indian woman.  Duration of study: from start of study till data collection and analysis , approximately 3 years. however no follow up shall be done as part of this study 
 
Target Sample Size   Total Sample Size="331"
Sample Size from India="331" 
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)   23/06/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   trial has not been started as yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is the most frequent cancer seen in woman. It was initially thought to be a disease of the elderly woman having certain risk factors like early menarche, late menopause, nulliparity, lack of breast feeding and westernised life style (which would also partly explain increased ocurence of the above mentioned risk factors). The incidence of this disease in India is  increasing and it seen to occur in woman at an age which is almost a decade younger than the western counterparts. Also, most of the woman do not harbor the known risk factors as Indian society has largely well preserved family structure where marrige, child birth and breast feeding still are a standard cultural norm. Despite these facts, breast cancer has become the most common cancer in woman in five of the six population based cancer registeries (PBCRs) in India. While Urbanization and adoption of westernized lifestyle may explain the rising incidence in the urban PBCRs in India, the statisticallysignificant increase in age adjusted rate over time (1982–2014) of 1.87% seen even at the rural PBCRs at Barshi makes it all the more important to identify the“at risk factors” existing in this ethnic and geographic region of the globe. Because of lack of these classical risk factors in indian woman, the breast cancer risk assessment tools (BRCAT) developed and validated in the western world do not largely apply to our woman and hence underestimate the risk of developing breast cancer in the India woman. Keeping these points in mind, we want to study the risk factors for development of breast cancer present in our Indian woman and try to develop and validate a breast cancer risk assessment tool, which will estimate the risk of developing breast cancer in indian woman. This may also help in developing breast cancer prevention programes and mechanisms in the future. Also, this will help in identifying the “at risk” woman so that they may be selectively  offered image based (mammographic) screening in a resource limited country like ours. 

 
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