Breast cancer screening by clinical breast examination and a new instrument named iBreastExam

Phase 4

Completed

Conditions: breast cancer

Registration Number: CTRI/2020/01/022727

Lead Sponsor: Prayas

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 4000

Inclusion Criteria

Consenting women.

Exclusion Criteria

Women who have undergone breast surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The outcome will be women detected with breast cancer correctly by clinical breast examination and iBreastExam	single
2. Test performance of clinical breast exam and iBreastExam in detecting breast cancer	single

Secondary Outcome Measures

Name	Time	Method
To study the test performance of CBE and iBreastExam in detecting lumps with histopathology as the reference standard

Trial Locations

Locations (1): Prayas
🇮🇳
Pune, MAHARASHTRA, India
Prayas
🇮🇳Pune, MAHARASHTRA, India
Dr Smita Joshi
Principal investigator
9881132506
smitanjoshi18@gmail.com