RecruitingNot ApplicableNCT06896162

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

500 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a program that uses genomic (genetic) testing of tumors to match cancer patients with the most appropriate clinical trials and personalized treatments. Instead of a one-size-fits-all approach, this 'precision oncology' strategy looks at the unique genetic makeup of each person's cancer to identify which targeted therapies or trials might be most effective for them. The program also tracks long-term outcomes to learn what works best. **You may be eligible if...** - You are 18 years or older and have been diagnosed with cancer - You are willing to have your tumor or blood tested for genetic changes - You are able to provide consent and comply with study follow-up - You are under the care of a participating oncologist **You may NOT be eligible if...** - You are unable or unwilling to provide consent - You do not have a cancer diagnosis that qualifies under the study criteria - You are unwilling to have genomic testing performed on your tumor - You are participating in another study that prevents enrollment here Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExpert 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.

OTHERBlood or tissue samples collection.

Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.

OTHERThe 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.