Precision oncology navigation with expert genomic review to guide therapy and survival
Official title: PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Run by UNC Lineberger Comprehensive Cancer Center · NCT06896162 · Data updated 2026-11-12
This tests whether a centralized precision oncology navigator and expert review of NGS results increase the use of genome-informed therapies for people with stage IV breast, lung, colorectal, or bladder cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT06896162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with stage IV NSCLC, colorectal, breast, or bladder cancer, ECOG/Karnofsky performance status 0–2, whose clinician deems NGS appropriate and who have not yet had actionable genomic results are ideal candidates.
✕Probably not a fit
Patients with an active concurrent malignancy, those whose tumors lack actionable genomic alterations, or those who already have completed and resulted NGS with available GIT are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a hybrid decentralized, single-arm interventional approach that pairs a centralized precision oncology navigator with reflexive expert review of next-generation sequencing (NGS) results by a precision oncology pharmacist and embedded clinical decision support. The intervention aims to make ordering, interpretation, and follow-up of multigene NGS testing easier for treating clinicians, with documented recommendations integrated into the electronic health record. The primary goal is to increase ordering of Level 1/2 genome-informed therapies compared to an estimated historical rate of 15%, with secondary endpoints including enrollment in biomarker-directed trials and overall survival at two years after return of NGS results. Enrollment is planned over ~12 months with two years of follow-up after NGS results are returned.
Why it matters
Potential benefit: If successful, more patients could receive guideline-matched targeted therapies and potentially experience better clinical outcomes through increased use of genome-informed treatments.
How similar studies have gone: Prior work shows higher NGS testing and targeted therapy use at NCI-designated centers and improved survival after molecular tumor board review in lung cancer, but a centralized navigator plus reflexive pharmacist review is a more novel, scalable model.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Carrie Lee — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Stephanie Drotts
- Email: stephanie_drotts@med.unc.edu
- Phone: 919-445-4872
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.