NCT06896162

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Malignancies
• Metastatic Cancer
• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Expert Review	Expert reflexive review of next-generation sequencing (NGS) results will be visible in electronic health records (EPIC) for provider review at the University of North Carolina Health System. Expert review will include recommendations for Genome-informed therapy (GIT), identification of available clinical trials, recommendations for additional testing, and/or referrals for genetic counseling.
OTHER	Blood or tissue samples collection.	Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
OTHER	The Precision Oncology Navigation	The precision oncology navigator will coordinate the collection of blood and /or tissue for next-generation sequencing (NGS), as well as order the NGS if not already ordered. Precision oncology navigator will also assist in NGS financial aid applications, if applicable.

Timeline

• Start date: 2025-06-27
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-03-26
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States