Breast cancer risk assessment model for Indian women
- Conditions
- Breast cancer
- Registration Number
- CTRI/2018/06/014362
- Lead Sponsor
- AIIMS Delhi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 331
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To develop an breast cancer risk assessment model applicable to Indian women, as feasible. 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 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 Measures
Name Time Method To study the clinico-epidemiologic and reproductive risk factors for breast cancer in Indian woman. 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
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, New Delhi
🇮🇳South, DELHI, India
All India Institute of Medical Sciences, New Delhi🇮🇳South, DELHI, IndiaSuhaniPrincipal investigator9810534358drsuhani@gmail.com