Prospective multicenter observational study of an integrated Artificial Intelligence system with live monitoring

Recruiting

• Conditions: C50; D05; Malignant neoplasm of breast; Carcinoma in situ of breast

• Registration Number: DRKS00027322
• Lead Sponsor: Vara (MX Healthcare GmbH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 400000

Inclusion Criteria

Attending biennial breast cancer screening at a screening unit participating in the German national breast cancer screening program.

Exclusion Criteria

None

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
I. Screen-detected cancer rate<br>Defined as the number of true-positive examinations divided by the total number of screening mammograms, per 1000 women screened. True-positive mammogram is a positive mammogram (BI-RADS assessment =3) followed by the biopsy-confirmed diagnosis of breast cancer within the timeframe as defined by the mammography screening program. <br><br>II. Recall rate<br>Defined as the number of surveillance imaging examinations with BI-RADS assessment =3 at consensus conference and recalled for further imaging, per 1000 women screened.