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Идёт набор NCT07327970

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

— Наблюдательное Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: multi-modal foundation AI test.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Non-Interventional Study Using a Multi-Modal Prognostic Test (Ataraxis) for Evaluating the Clinical Integration in Early-Stage Invasive Breast Cancer

Обзор

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.

Вмешательства

  • Диагностический тест multi-modal foundation AI test
    Multi-modal AI test combining digital pathology features from H\&E-stained core needle biopsy slides with clinical information (age, molecular biomarkers, TNM stage) to generate a continuous risk score (0-1) predicting pathological complete response. Results provided as reference information only; does not influence treatment decisions.

Первичные конечные точки

  • Stage 1 - Feasibility: Clinical Workflow Compatibility Score [Срок оценки: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
  • pCR Prediction: pCR Prediction Accuracy (AUC-ROC) [Срок оценки: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
Вторичные конечные точки (5)
  • Subtype-specific pCR Prediction Accuracy [Срок оценки: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
  • Sensitivity and Specificity of pCR Prediction [Срок оценки: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
  • AI Test Processing Time [Срок оценки: Within 2 weeks after enrollment]
  • Hypothetical Treatment Change Rate [Срок оценки: After AI result disclosure following surgery (approximately 5-7 months per participant)]
  • Correlation Between AI Score and Established Prognostic Factors [Срок оценки: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Incheon

Идентификаторы

NCT: NCT07327970 · ATARAXIS NEOP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗