PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
UNC Lineberger Comprehensive Cancer Center
500 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
Exclusion Criteria1
- • Subjects with an active concurrent malignancy.
Interventions
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.
Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06896162