A pilot study for breast cancer screening by clinical breast examination (CBE) and iBreastExam (iBE) for early detection of breast cancer

Breast cancer is the most common cancer among women in India. Mammography screening is the mainstay of breast cancer screening in the developed / high-income countries however such organized screening programmes are extremely difficult/ expensive to implement in the low- and middle-income countries. Hence alternative screening strategies must be evaluated.    iBreastExam is a new technology that is approved by the USFDA and is approved in India. According to the World Health Organization (WHO), screening programmes should be undertaken only when their effectiveness has been demonstrated, when resources are sufficient to cover nearly all of the target group, when facilities exist for follow-up of those with abnormal results to confirm diagnoses and ensure treatment and when prevalence of the disease is high enough to justify the effort and costs of screening. We are proposing a study to evaluate the diagnostic performance characteristics of  Clinical Breast Examination (CBE)  and iBreastExam for the early detection of breast cancer. Previous studies have been conducted in hospital settings and among women visiting the hospital/ breast clinic. Our study will be conducted in a community setting and women who test positive by either CBE or iBreastExam will be referred to an Expert Breast Surgeon. Those who are detected as being normal / negative by the breast surgeon will be assured and will be sent back. Women who have a lump detected by the breast surgeon on CBE will undergo triple diagnostic tests including FNAC for the final diagnosis.