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Not yet recruiting NCT07232043

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

No phase Interventional Cancer

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MatchMiner-AI Artificial Intelligence Tool.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Proportion clinical trials [Time frame: Assessment will occur at the end of the 1.5 year duration of the intervention.]
Secondary outcome measures (3)
  • Proportion clinical trials by race [Time frame: 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.]
  • Proportion clinical trials by age [Time frame: Assessment will occur at the end of the 1.5 year duration of the intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT07232043 · 25-413 · 1R37CA295653-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗