A study to evaluate the effectivity of Portable Ultrasound Device in differentiating benign and malignant disease in patients with palpable breast lump

Not Applicable

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2023/03/050522
• Lead Sponsor: International Agency for Research on Cancer (World Health Organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Women positive on CLinical Breast Examination

Exclusion Criteria

Women with debilitating illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the agreement between PUD and mammography /ultrasound by a radiologist in differentiating malignant and benign solid breast lesionsTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.

Secondary Outcome Measures

Name	Time	Method
To collect annotated images of breast ultrasound for future development of artificial algorithm in breast cancer detectionTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.;To develop a diagnostic algorithm that incorporates PUD in the triage of breast lumps detected on CBE to avoid unnecessary imaging and biopsy procedures for benign lumpsTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.