PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival (PROGRESS)
July 10, 2026 updated by: UNC Lineberger Comprehensive Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets.
Rates of multigene panel-based testing and targeted therapy use are reported to be higher at NCI-designated cancer centers compared to other practice types, even when they are associated with a "hub" site.
Molecular tumor boards have demonstrated improvements in overall survival in lung cancer, but these models rely on consults being placed by treating physicians and/or significant institutional resources.
Many studies evaluating interventions to increase the use of genome informed therapy (GIT) focus on a single cancer type, thereby hindering the ability to operationalize supportive interventions broadly across all cancer types.
Given the collective body of data supporting meaningful clinical improvements when patients have access to GIT, we want to study if interventions that make NGS test ordering and interpretation easier for clinicians will increase the rate of orders for GIT.
The use of a centralized precision oncology navigator to facilitate completion of NGS testing, expert clinical review from a clinical pharmacist, and documented clinical decision support embedded in the electronic health record represents a unique and more easily scalable model than full molecular tumor board reviews.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie Drotts
- Phone Number: 919-445-4872
- Email: stephanie_drotts@med.unc.edu
Study Contact Backup
- Name: Douglas Kirk
- Phone Number: 919-445-6240
- Email: douglas_kirk@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- Lineberger Comprehensive Cancer Center, University of North Carolina
-
Contact:
- Carrie Lee, MD
- Phone Number: 919-966-0405
- Email: carrie_lee@med.unc.edu
-
Principal Investigator:
- Carrie Lee, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: The potential candidates for genome-informed targeted therapy
Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of genome informed therapy (GIT) orders
Time Frame: 2 years
|
The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: 2 years
|
Overall survival of enrolled patients who receive precision oncology navigation order facilitation and reflexive expert review of their Next Generation Sequencing (NGS) result reporting to the date of death for any cause.
|
2 years
|
|
The rate of genome informed therapy (GIT) orders by site
Time Frame: 2 years
|
The rate of orders for Level 1/2 genome informed therapy (GIT) at each site.
|
2 years
|
|
The rates of consent to UNC Health biomarker-selective clinical trials
Time Frame: 2 years
|
The rates of consent to the University of North Carolina (UNC) Health biomarker-selective clinical trial will be calculated.
A subgroup analysis of rates of consent by site may be performed.
|
2 years
|
|
The reasons for non-consent
Time Frame: 2 years
|
Among enrolled patients, if a biomarker-selective clinical trial is identified on expert review of Next Generation Sequencing (NGS) results, reasons for non-consent will be collected.
|
2 years
|
|
Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)
Time Frame: 2 years
|
To determine the overall survival (OS) after the return of Next Generation Sequencing (NGS) results in those deemed eligible for Level 1/2 genome-informed therapy (GIT) in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
|
2 years
|
|
The rates of referrals for full Molecular Tumor Board
Time Frame: 2 years
|
The rates of referrals for full Molecular Tumor Board review in patients who receive precision oncology navigator order facilitation and reflexive expert review of results will be calculated.
|
2 years
|
|
The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials
Time Frame: 2 years
|
To determine the combined rate of orders for Level 1/2 genome-informed therapy (GIT) and consent to biomarker-directed clinical trials open at UNC. Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results.
|
2 years
|
|
The time between the date of NGS results and the Level 1/2 GIT order date
Time Frame: 2 years
|
The time between the date of Next Generation Sequencing (NGS) results and the order date of Level 1/2 GIT will be calculated for those with GIT orders and reported by the site.
The median time will be reported for enrolled patients.
|
2 years
|
|
Reasons for lack of Level 1/2 GIT orders in eligible subjects
Time Frame: 2 years
|
Reasons why patients deemed eligible for Level 1/2 genome-informed therapy (GIT) by expert review do not have orders for GIT will be collected.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carrie Lee, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
March 14, 2025
First Submitted That Met QC Criteria
March 19, 2025
First Posted (Actual)
March 26, 2025
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Respiratory Tract Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Neoplastic Processes
- Skin Diseases
- Breast Diseases
- Urologic Neoplasms
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Lung Neoplasms
- Colorectal Neoplasms
- Breast Neoplasms
- Neoplasm Metastasis
- Urinary Bladder Neoplasms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- LCCC2437-DCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.