NCT07327970 Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer
| NCT ID | NCT07327970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Young-Joon Kang |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-20 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 against actual surgical outcomes. This study uses a blinded design where treating physicians remain blinded to AI results until post-surgical pCR assessment. AI analysis is performed by the research coordinator in collaboration with Ataraxis. After pCR evaluation, AI results are disclosed and physicians complete surveys assessing hypothetical treatment changes. This design eliminates AI influence on treatment decisions and ensures independent validation. Participants are adults with Stage I-III breast cancer planned for neoadjuvant chemotherapy. The study involves no additional procedures beyond standard care except for completing surveys about the AI test experience.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07327970 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07327970 currently recruiting?
Yes, NCT07327970 is actively recruiting participants. Contact the research team at yjkang.md@gmail.com for enrollment information.
Where is the NCT07327970 trial being conducted?
This trial is being conducted at Incheon, South Korea.
Who is sponsoring the NCT07327970 clinical trial?
NCT07327970 is sponsored by Young-Joon Kang. The trial plans to enroll 150 participants.
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