Trial: PROGRESS: Precision Oncology Using Geno…

Trial Details

Sponsor: UNC Lineberger Comprehensive Cancer Center (other)

Phase: NA

Start date: June 27, 2025

Planned enrollment: 500

Trial ID: NCT06896162

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.

More details:

Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets. Rates of multigene panel-based testing and targeted therapy use are reported to be higher at NCI-designated cancer centers compared to other practice types, even when they are associated with a "hub" site. Molecular tumor boards have demonstrated improvements in overall survival in lung cancer, but these models rely on consults being placed by treating physicians and/or significant institutional resources. Many studies evaluating interventions to increase the use of genome informed therapy (GIT) focus on a single cancer type, thereby hindering the ability to operationalize supportive interventions broadly across all cancer types. Given the collective body of data supporting meaningful clinical improvements when patients have access to GIT, we want to study if interventions that make NGS test ordering and interpretation easier for clinicians will increase the rate of orders for GIT. The use of a centralized precision oncology navigator to facilitate completion of NGS testing, expert clinical review from a clinical pharmacist, and documented clinical decision support embedded in the electronic health record represents a unique and more easily scalable model than full molecular tumor board reviews.

Investigational Drug AI Analysis

No investigational drugs.

HealthScout AI Analysis

Goal: The goal of this trial is to determine whether centralized precision oncology navigation and reflexive expert review of next-generation sequencing (NGS) results can increase the rate of orders for Level 1/2 genome-informed therapy (GIT) in patients with stage IV solid tumors. Additionally, the trial aims to assess the impact of these interventions on biomarker-directed clinical trial enrollment and overall survival.

Patients: The study includes adult patients (age ≥ 18) with ECOG or Karnofsky performance status 0-2 and stage IV solid tumor malignancies including non-small cell lung cancer, colorectal cancer, breast cancer, or bladder cancer. Participants must be candidates for NGS testing, with testing planned prior to first or second-line therapy in the metastatic setting. Patients with active concurrent malignancies are excluded.

Design: This is a hybrid decentralized, single-arm interventional study enrolling approximately 500 patients. There is no randomization or control arm. Patients are followed for approximately 2 years following receipt of NGS results to assess outcomes related to the intervention.

Treatments: The interventions being studied include facilitation by a centralized precision oncology navigator, reflexive expert review of NGS results by a pharmacist, and supporting clinical decision tools incorporated into the electronic health record. There are no experimental drugs administered as part of the study; rather, the focus is on enhancing the implementation of precision oncology practices using existing targeted therapies and supporting clinical trial referral.

Outcomes: The primary outcome is the rate of orders for Level 1/2 genome-informed therapy (GIT) compared to a baseline historical rate. Secondary outcomes include overall survival, rates of GIT orders by site, rates of consent to biomarker-selective clinical trials, reasons for non-consent, rates and timing of molecular tumor board referrals, reasons for lack of GIT orders in eligible patients, and time from NGS results to GIT order.

Burden on patient: The patient burden is expected to be low to moderate. The main additional procedures involve collection of blood or tissue samples for NGS testing, which is typically considered standard of care in the metastatic setting. The navigation and expert review interventions are administrative and do not require extra clinic visits or additional invasive testing beyond what would be standard. There may be increased communications regarding clinical trial opportunities or GIT options, but these do not generally increase physical or logistical burden.

Eligibility

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Sites (1)

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Lineberger Comprehensive Cancer Center, University of North Carolina

Chapel Hill, North Carolina, 27599, United States

[email protected] / 919-966-0405

Status: Recruiting

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival