Compare Diagnostic Performance of Breast Cancer Screening interventions of Breast Care Glove and Clinical Breast Examination (CBE) by Primary Health Worker with that of Physician CBE Findings and /or Mammography for Early Detection of Breast Cancer in India.
Not Applicable
- Registration Number
- CTRI/2024/02/063024
- Lead Sponsor
- ICST Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy non pregnant women
Exclusion Criteria
1. Women diagnosed with breast cancer
2. Pregnant women
3. Women below 40 years
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary end points are the sensitivity, specificity, accuracy and the positive and negative predictive values of the Breast cancer screening tools.Timepoint: 24 months
- Secondary Outcome Measures
Name Time Method The Secondary end-point are <br/ ><br>a)Detection rates for detecting any breast lesion & suspicious breast lesions by the two screening methods. <br/ ><br>b)Concordance of conventional clinical Breast examination [CBE] with that using the Breast Care Glove by Trained PHW <br/ ><br>Timepoint: 24 months