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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Breast cancer, |
|
Intervention / Comparator Agent
|
|
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. |