About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
MatchMiner-AI Artificial Intelligence Tool
Other interventionOncologists receive email notifications containing a ranked list of potential clinical trial options when AI models detect progressive disease, in addition to standard MatchMiner-AI access.
Treatment groups
Trial outcomes
Primary outcomes
Proportion clinical trials
The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials.
Secondary outcomes
Proportion clinical trials by race
The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials. The outcome will be stratified by race categories of: American Indian/Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African America, White, and More than One Race.
Proportion clinical trials by ethnicity
The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials. The outcome will be stratified by ethnicity (Hispanic or non-Hispanic)
Proportion clinical trials by age
The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials. The outcome will be stratified by Age categories of: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, 70-79 years, 80-89 years, and 90+ years.
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator