Breast cancer is the most common cancer among women in India. Mammography screening is the mainstay of breast cancer screening in developed / high-income countries; however, such organized screening programs are challenging/ expensive to implement in low- and middle-income countries. Hence alternative screening strategies must be evaluated. iBreastExam is a new technology approved by the USFDA and approved in India. According to the World Health Organization (WHO), screening programs 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 the prevalence of the disease is high enough to justify the effort and costs of screening. The study was proposed 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. This study is being conducted in a community setting, and women who test positive by either CBE or iBreastExam are being 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.

Objectives:

• To evaluate the agreement between CBE and iBreastExam in the detection of breast lumps
• To study the test performance of CBE and iBreastExam in detecting lumps with histopathology as the reference standard
• To study the detection rate, false positive and false negative rates and positive predictive value of iBreastExam and CBE in detecting breast cancers confirmed by histopathology

Type of research: Open-label, cross-sectional study

Investigators:

Dr. Smita Joshi (Principal Investigator)

Dr. Shekhar Kulkarni (Co-Investigator)

Dr. Neelam Kolte (Co-Investigator)

Funding: Atlas Copco Charitable Foundation

Start date: January 2020

End date:  September 2023