Health Condition 1: D249- Benign neoplasm of unspecified breast
Conditions
Interventions
Intervention1: Breastlight: Breastlight is a low cost, feasible and point of care technology to triage CBE positive women will greatly improve the efficiency of CBE screening.
Control Intervention1: N
Sponsors
NICPR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 30-69 years without any prior diagnosis of breast cancer, referred to the Breast Clinics at the study centers due to breast abnormalities detected on clinical breast examination will be recruited in the study after informed consenting. 2. Women of any age requiring examination of the contralateral breast due to prior diagnosis of breast cancer will also be recruited to the study
Exclusion criteria
Exclusion criteria: 1. Women diagnosed with breast cancer 2. Women not consenting for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, negative and positive predictive values of Breastlight with mammography and/or cytology/core biopsy as the gold standard verification test 2. The agreement between the breastlight and ultrasound diagnosis 3. Improvement in the PPV of CBE by Breastlight triaging 4. Loss in the sensitivity of CBE by Breastlight triaging Timepoint: At confirmation by tissue diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Size (T status) of the breast cancer according to Breastlight resultsTimepoint: After the staging workup | — |
Countries
India
Contacts
Public ContactRoopa Hariprasad
National Institute of Cancer Prevention and Research
Outcome results
None listed