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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedExpert Review and Blood or tissue samples collection.

Plus 1 other study approaches.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: UNC Lineberger Comprehensive Cancer Center
Interventions being studied: Other: Expert Review; Other: Blood or tissue samples collection.; Other: The Precision Oncology Navigation

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

Subjects with an active concurrent malignancy.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Lineberger Comprehensive Cancer Center, University of North CarolinaChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2026. Always confirm current availability with the study team.

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