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.
Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
Age ≥ 18 years at the time of consent.
ECOG or Karnofsky Performance Status of 0-2.
None
Single group
Expert Review
Other interventionExpert 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.
Other interventionBlood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
The Precision Oncology Navigation
Other interventionThe 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.
The rate of genome informed therapy (GIT) orders
The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order.
Overall survival (OS)
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
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
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
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.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator
