ACTIVATE: AI-driven Clinical-trial Trial-Information and Viability Assessment Tool for EHRs

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MatchMiner-AI Artificial Intelligence Tool

    Other intervention

    Oncologists 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

70,000 Participants
are divided into 2 treatment groups
Group A: Standard MatchMiner-AI WorkflowNo intervention 0 interventions
Group B: Proactive AI-Triggered NotificationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion clinical trials

The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials.

Time frame
Assessment will occur at the end of the 1.5 year duration of the intervention.

Secondary outcomes

1

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.

Time frame
Assessment will occur at the end of the 1.5 year duration of the intervention.
2

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)

Time frame
Assessment will occur at the end of the 1.5 year duration of the intervention.
3

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.

Time frame
Assessment will occur at the end of the 1.5 year duration of the intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator