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PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Sponsor: UNC Lineberger Comprehensive Cancer Center
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-06-27
Completion Date
2028-06
Last Updated
2025-07-11
Healthy Volunteers
No
Conditions
Interventions
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.
Blood or tissue samples collection.
Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
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.
Locations (1)
Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, North Carolina, United States