Deep Clinical Trajectory Modeling to Optimize Accrual to Cancer Clinical Trials

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT06888089
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This study aims to evaluate the effectiveness of proactive notifications to treating oncologist to optimize participant accrual to clinical trials by utilizing the MatchMiner AI platform. This study compares the standard MatchMinder AI access method to two enhanced recruitment methods.

Detailed Description

The goal of this medical record data analysis and health system implementation study is to evaluate the effectiveness of proactive notifications to treating oncologist to optimize participant accrual to clinical trials by utilizing the MatchMiner platform. This study compares the standard MatchMinder access method to two enhanced recruitment methods.

In the first phase, investigators will provide qualitative feedback to improve AI algorithm impact on clinical trial accrual and the delivery of information from the MatchMiner platform that is utilized by treating oncologists and investigators.

In the second phase, medical records identified by the MatchMiner platform as available or a "match" for clinical trial enrollment will be randomized into three cohorts with the randomization occurring at the participant level. In Group 1, treating oncologists can use MatchMiner in its traditional form to identify potential clinical trial candidates based on structured genomic data and cancer type. In Group 2, treating oncologists will automatically receive emails with lists of potential genomically matched clinical trials identified by MarchMiner for patients in whom our AI algorithm detects an elevated probability of changing treatment based on imaging reports; oncologists can also still use traditional MatchMiner workflows. In Group 3, treating oncologists will receive email lists of genomically matched clinical trials identified by Matchminer for patients with AI-detected elevated probability of treatment change, after additional manual review to confirm that patients had progressive diseased based on their imaging reports and did not meet one of the common exclusion criteria for most cancer trials (including uncontrolled brain metastases, multiple primary cancers, poor performance status, lack of measurable disease, already having changed treatment, and hospice enrollment).

Of note, this study was not itself considered a clinical trial during the initial NCI grant application process or on subsequent discussion with NIH staff, since the outcomes were research processes (whether patients enrolled in other therapeutic clinical trials), not health-related patient outcomes as per the NIH definition of a clinical trial. However, for publication, a medical journal determined that the study met ICMJE criteria for a clinical trial and requested that it be registered.

Study Timeline

• Study Start: 2023-01-30
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20707

Inclusion Criteria

-≥ 18 years of age

-adults with any type of cancer whose tumors underwent OncoPanel genomic sequencing from 2013-2022

Exclusion Criteria

-≤ 18 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Enrolling in Any Dana-Farber Cancer Institute Therapeutic Clinical Trial of Anti-Cancer Systemic Therapy	Up to 18 months	This measure assesses the proportion of patients in each study arm who enroll in any Dana-Farber Cancer Institute (DFCI) therapeutic clinical trial involving anti-cancer systemic therapy during the intervention period. Trial enrollment data will be pulled from the institutional OnCore database.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Having Consultations with the Center for Cancer Therapeutic Innovation (CCTI)	Up to 18 months	Counts the number of patients in each study arm who have at least one consultation with the CCTI at Dana-Farber Cancer Institute during the intervention period. Encounters with the CCTI will be pulled from the institutional Enterprise Data Warehouse.
Percentage of Patients Consenting to Any Clinical Trial of an Anti-Cancer Systemic Therpay	Up to 18 months	Counts the proportion of patients in each study arm who provide consent to participate in any therapeutic clinical trial during the intervention period. Trial consent data will be pulled from the institutional OnCore database.
Percentage of Patients Predicted to Change Treatment Who Enroll in Any Therapeutic Clinical Trial	Up to 18 months	Assesses the proportion of patients identified by our AI model as likely to change treatment within the next 30 days who subsequently enroll in any DFCI therapeutic clinical trial involving anti-cancer systemic therapy. Trial enrollment data will be pulled from the institutional OnCore database.
Percentage of New Systemic Therapy Initiations That Are Clinical Trials of Anti-Cancer Systemic Therapies	Up to 18 months	Determines the proportion of new systemic therapy regimens initiated during the intervention period that are part of a therapeutic clinical trial. New systemic therapy initiations will be pulled from the institutional Enterprise Data Warehouse, and clinical trial enrollment data will be pulled from the institutional OnCore database.
Clinician Opt-Out Rate from Ongoing Email Notifications	Up to 18 months	Measures the percentage of clinicians in each intervention arm (Groups 2 and 3) who opt out of receiving ongoing email notifications from the study. This will be measured using physician survey responses.
Comparison of Anti-Cancer Systemic Therapy Clinical Trial Enrollment Proportions Between AI-Assisted Intervention Arms (Groups 2 and 3)	Up to 18 months	Compares the percentage of patients enrolling in any DFCI therapeutic clinical trial of anti-cancer systemic therapy between Group 2 and Group 3 to evaluate the effectiveness of automated notifications versus notifications after manual review. Trial enrollment data will be pulled from the institutional OnCore database.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States