NCT06896162 PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
| NCT ID | NCT06896162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Solid Tumor Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-06-27 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Carrie Lee
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06896162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896162 currently recruiting?
Yes, NCT06896162 is actively recruiting participants. Contact the research team at stephanie_drotts@med.unc.edu for enrollment information.
Where is the NCT06896162 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06896162 clinical trial?
NCT06896162 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Carrie Lee at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 500 participants.