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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Colorectal Cancer; Lung Cancer; Metastatic Cancer; Bladder Cancer; Solid Tumor Malignancies
• Intervention / Treatment: Other: Expert Review; Other: Blood or tissue samples collection.; Other: The Precision Oncology Navigation

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Drotts; Phone Number: 919-445-4872; Email: stephanie_drotts@med.unc.edu
• Study Contact Backup: Name: Douglas Kirk; Phone Number: 919-445-6240; Email: douglas_kirk@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Lineberger Comprehensive Cancer Center, University of North Carolina
      • Contact: Carrie Lee, MD; Phone Number: 919-966-0405; Email: carrie_lee@med.unc.edu
      • Principal Investigator: Carrie Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria

• 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.
• Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer
• The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting
• A genomic tumor test has not been ordered or has been ordered but not resulted.

Exclusion Criteria:

• Subjects with an active concurrent malignancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: The potential candidates for genome-informed targeted therapy; Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 years
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.	2 years
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.	2 years
Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)	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.	2 years
The rates of referrals for full Molecular Tumor Board	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.	2 years
The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials	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.	2 years
The time between the date of NGS results and the Level 1/2 GIT order date	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.	2 years
Reasons for lack of Level 1/2 GIT orders in eligible subjects	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.	2 years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Carrie Lee, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: precision oncology; next-generation sequencing (NGS); expert review of NGS; precision oncology navigator; genome informed therapy (GIT); biomarker-directed clinical trials
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LCCC2437-DCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No