NCT06896162Recruiting
PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 14 Mar 2025
- Start date
- 27 Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Bladder cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT06896162
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 27 Jun 2025 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with an active concurrent malignancy.
Who the study is looking for
- 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.
Criteria the registry did not label
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center, University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.