Safe and Explainable AI
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Study ID
- NCT06694181
- Status
- Recruiting
Conditions
- Artifical Inteligence
- Breast Cancer
- Cardiology
- Sepsis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AI-PERSONALIZED CLINICAL DECISION SUPPORT — OTHERAI-ENABLED DECISION MAKING FOR PERSONALIZED CLINICAL DECISION SUPPORT
Study Details
While current AI technology is suitable for automating some repetitive clinical tasks, technical challenges remain in solving critical and gainful problems in the domains of patient and disease management. The proposed research seeks to address issues in medical AI, such as integrating medical knowledge effectively, making AI recommendations explainable to clinicians, and establishing safety guarantees.
Key Dates
- Start date
- Nov 29, 2025
- Status verified
- Feb 2026
- Primary completion
- Nov 30, 2028
- Completion
- Nov 30, 2028
Study Design
- Enrollment
- 300,000 participants (estimated)
Arms
- Arm: CardiologyThe primary objective in this clinical case scenario is to evaluate an ML model utilizing real-time cardiac telemetry, as well as other clinical, demographic, and imaging structured data sources, among hospitalized, intensive care unit (ICU) patients to predict impending inhospital cardiac arrest, identify potentially reversible causes of cardiac arrest, and predict which patients may have impending cardiac arrest due to shockable rhythms i.e. ventricular tachycardia (VT) or ventricular fibrillation (VF).
- Arm: Oncology - Breast CancerThe primary objective in this clinical case scenario is to evaluate an ML model utilizing structured and unstructured data from clinical, demographic, and tumor molecular and germline sequencing, among outpatients with cancer, to predict short-term mortality and/or symptom decline. The model for prediction to treatment response in breast cancer patients will be compared with two prognostic tools: 1) Conversation Connect, a previously validated machine learning mortality prediction tool that has been used at the University of Pennsylvania for routine clinical decision support, and 2) the Elixhauser Comorbidity Index, a comorbidity-based prognostic index used commonly in research and risk-adjustment.
- Arm: SepsisThe primary objective in this clinical case scenario is to develop and evaluate an ML model that utilizes multidmodal clinical data (e.g., structured EHR data such as demographics, laboratory test results, and vital signs; unstructured EHR data including the text of clinical encounter notes and, where available, waveforms from real-time cardiac, hemodynamic, and respiratory monitoring devices) to predict the need for initiation of broad-spectrum antimicrobial therapy for hospitalized patients with sepsis. With a focus on implementable and explainable AI, we will produce well calibrated predictions that are also clinically meaningful at the bedside to aid real-time decision-making about diagnosis and treatment initiation. The model for timely diagnosis and intervention in sepsis will be compared with widely used commercial and open-source sepsis prediction models.
Primary Outcome Measure
Neurosymbolic Learning Algorithms [ Time Frame: Prototype and develop new learning algorithms; 18 months. Benchmark and evaluate the learning algorithms; 24 months. Publish research results; 24 months ]
Central Contacts
- Haideliza Soto Calderon215-220-9425
- Nicholas Bishop
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 |
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