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Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer

Recruitingn/aAges 18 Years - anyFemaleYoung-Joon Kang
NCT07327970 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study evaluates the real-world clinical workflow integration of a previously developed artificial intelligence (AI) prognostic test in breast cancer patients receiving neoadjuvant chemotherapy, and validates its accuracy in predicting treatment response. The Ataraxis AI test analyzes digitized images of tumor biopsy slides combined with basic clinical information (age, tumor stage, hormone receptor status) to generate a risk score. Prior studies showed the AI test can predict cancer recurrence with accuracy comparable to or better than existing genomic tests. The study has two stages: * Stage 1 (30 patients): Assess whether the AI test can be practically integrated into routine clinical workflow, including ease of use, report clarity, and time requirements. * Stage 2 (70-120 additional patients): Validate the accuracy of AI-predicted pathological complete response (pCR) rates aga

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed Stage I-III invasive breast cancer * Planned for neoadjuvant chemotherapy * H\&E-stained slides available from core needle biopsy * Age 18 years or older * Able to provide written informed consent Exclusion Criteria: * Metastatic breast cancer (Stage IV) * Not a candidate for neoadjuvant chemotherapy * H\&E slides not obtainable from core needle biopsy * Unable to provide informed consent
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What it tests

  • multi-modal foundation AI test
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Where

1 site
Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Incheon, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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