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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Carrie Lee · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-27

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• United States

Study Locations