Actively Recruiting
PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-07-11
500
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Willing and able to follow study procedures
- Age 18 years or older
- ECOG or Karnofsky Performance Status between 0 and 2
- Diagnosed with stage IV non-small cell lung cancer, colorectal cancer, breast cancer, or bladder cancer
- Treating provider considers NGS testing appropriate and plans to use results in first- or second-line metastatic therapy
- No prior genomic tumor test ordered or test ordered but results not yet available
You will not qualify if you...
- Having an active concurrent malignancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
S
Stephanie Drotts
CONTACT
D
Douglas Kirk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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