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

April 27, 2026 updated by: Kenneth Kehl, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

ACTIVATE is a pragmatic health system intervention designed to improve clinical trial matching and accrual using AI-driven tools integrated with EHR data. The study will first retrospectively analyze data from approximately 70,000 participants who initiated new systemic therapy at Dana-Farber Cancer Institute since 2016 to develop and validate the MatchMiner-AI pipeline.

For the prospective evaluation, all DFCI patients' medical record numbers (MRNs) will be randomized into control and intervention groups. The intervention group will receive proactive notifications to treating oncologists when AI models detect progressive disease and a high probability of starting new treatment, including a ranked list of potential clinical trial options. The control group will continue with standard MatchMiner-AI workflows.

Study Type

Interventional

Enrollment (Estimated)

70000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard MatchMiner-AI Workflow
Oncologists can access the MatchMiner-AI frontend website to obtain a list of clinical trial options for all participants.
Experimental: Proactive AI-Triggered Notifications
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.
Other: MatchMiner-AI Artificial Intelligence Tool
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.
Other Names:
  • MatchMiner-AI Pipeline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion clinical trials
Time Frame: Assessment will occur at the end of the 1.5 year duration of the intervention.
The effect of TrialMatch notifications is defined as the proportion of new systemic therapy starts which are clinical trials.
Assessment will occur at the end of the 1.5 year duration of the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion clinical trials by race
Time Frame: Assessment will occur at the end of the 1.5 year duration of the intervention.
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.
Assessment will occur at the end of the 1.5 year duration of the intervention.
Proportion clinical trials by ethnicity
Time Frame: Assessment will occur at the end of the 1.5 year duration of the intervention.
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)
Assessment will occur at the end of the 1.5 year duration of the intervention.
Proportion clinical trials by age
Time Frame: Assessment will occur at the end of the 1.5 year duration of the intervention.
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.
Assessment will occur at the end of the 1.5 year duration of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kenneth L Kehl, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-413
  • 1R37CA295653-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: kenneth_kehl@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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