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

NCT07232043 | Not Yet Recruiting

• 2 other identifiers: 25-4131R37CA295653-01A1
• Study Type: interventional
• Target: 70,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Cancer; Clinical Trial Enrollment; Electronic Health Records; Artificial Intelligence

Outcome Measures

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.

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

Secondary Outcomes (3)

• Proportion clinical trials by race

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

• Proportion clinical trials by ethnicity

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

• Proportion clinical trials by age

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

Study Arms (2)

Standard MatchMiner-AI Workflow

NO INTERVENTION

Oncologists can access the MatchMiner-AI frontend website to obtain a list of clinical trial options for all participants.

Proactive AI-Triggered Notifications

EXPERIMENTAL

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

Interventions

MatchMiner-AI Artificial Intelligence Tool OTHER

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.

Also known as: MatchMiner-AI Pipeline

Proactive AI-Triggered Notifications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kenneth L Kehl, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth L Kehl, MD

CONTACT

617-632-4550; kenneth_kehl@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)