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

Not Applicable

Recruiting

• Conditions: Solid Tumor Malignancies; Metastatic Cancer; Breast Cancer; Colorectal Cancer; Lung Cancer; Bladder Cancer

• Registration Number: NCT06896162
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Study Start: 2025-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

• Subjects with an active concurrent malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of genome informed therapy (GIT) orders	2 years	The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	Overall survival of enrolled patients who receive precision oncology navigation order facilitation and reflexive expert review of their Next Generation Sequencing (NGS) result reporting to the date of death for any cause.
The rate of genome informed therapy (GIT) orders by site	2 years	The rate of orders for Level 1/2 genome informed therapy (GIT) at each site.
The rates of consent to UNC Health biomarker-selective clinical trials	2 years	The rates of consent to the University of North Carolina (UNC) Health biomarker-selective clinical trial will be calculated. A subgroup analysis of rates of consent by site may be performed.
The reasons for non-consent	2 years	Among enrolled patients, if a biomarker-selective clinical trial is identified on expert review of Next Generation Sequencing (NGS) results, reasons for non-consent will be collected.
The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials	2 years	To determine the combined rate of orders for Level 1/2 genome-informed therapy (GIT) and consent to biomarker-directed clinical trials open at UNC. Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
The time between the date of NGS results and the Level 1/2 GIT order date	2 years	The time between the date of Next Generation Sequencing (NGS) results and the order date of Level 1/2 GIT will be calculated for those with GIT orders and reported by the site. The median time will be reported for enrolled patients.
Reasons for lack of Level 1/2 GIT orders in eligible subjects	2 years	Reasons why patients deemed eligible for Level 1/2 genome-informed therapy (GIT) by expert review do not have orders for GIT will be collected.
Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)	2 years	To determine the overall survival (OS) after the return of Next Generation Sequencing (NGS) results in those deemed eligible for Level 1/2 genome-informed therapy (GIT) in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
The rates of referrals for full Molecular Tumor Board	2 years	The rates of referrals for full Molecular Tumor Board review in patients who receive precision oncology navigator order facilitation and reflexive expert review of results will be calculated.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center, University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States