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Recruiting
NCT07232043
ACTIVATE: AI-driven Clinical-trial Trial-Information and Viability Assessment Tool for EHRs
Conditions: Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70000
Sponsor: Dana-Farber Cancer Institute
Location: Dana-Farber Cancer Institute Boston Massachusetts
Summary
This study aims to develop and evaluate ACTIVATE, an AI-driven tool for clinical trial information and viability assessment using electronic health records (EHRs). The project will leverage retrospective and prospective EHR data to build and validate algorithms that identify potentially eligible participants for clinical trials and facilitate trial matching.
Eligibility Criteria
Inclusion Criteria:
* 3.1 The potentially eligible patient population includes any adult (≥18 years old) with a cancer diagnosis receiving care at DFCI. No direct patient recruitment will occur as part of this protocol; all data will be obtained retrospectively or prospectively from routine clinical documentation and electronic health records. TrialForecast will involve aggregate queries of this dataset for cohort size estimation. The randomized interventional component (TrialMatch) is a health system level email "nudge" to treating oncologists providing a list of clinical trial options for patients who have progressive disease based on their imaging reports as detected using our previously developed, validated, and deployed AI model for that purpose. 23-25 Secondary outcomes in our study will include oncologist satisfaction with information delivered via these pipelines. All DFCI oncologists at any DFCI-owned/operated site (Longwood, Chestnut Hill, and regional campus sites) will be eligible to use our pipeline and may receive notifications about clinical trial options for their patients. In 2024, there were approximately 593 such oncologists who had outpatient appointments with at least one patient. Clinicians will constitute study participants as well, since they will have the opportunity to provide feedback on our pipeline to be analyzed by the study team.
* 3.2 Our project will focus on adults with cancer treated at DFCI, as above. We will not have any mechanism for identifying, targeting, or excluding pregnant women or prisoners.
Exclusion Criteria:
* 3.2 Our project will focus on adults with cancer treated at DFCI, as above. We will not have any mechanism for identifying, targeting, or excluding pregnant women or prisoners.
Source: ClinicalTrials.gov (NCT07232043). StuddyBuddy aggregates publicly available trial information.