Recruiting

Precision Medicine

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06896162

Conditions

Solid Tumor Malignancies

Metastatic Cancer

Breast Cancer

Colorectal Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Expert Review

Blood or tissue samples collection.

The Precision Oncology Navigation

Study Details

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.

Conditions

Solid Tumor Malignancies

Metastatic Cancer

Breast Cancer

Colorectal Cancer

Lung Cancer

Study ID

NCT06896162

Start date

Jun 27, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Expert Review

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 collection.

Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.

The Precision Oncology Navigation

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.

Primary outcome measure

  • The rate of genome informed therapy (GIT) orders [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Stephanie Drotts

919-445-4872stephanie_drotts@med.unc.edu

Douglas Kirk

919-445-6240douglas_kirk@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center, University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Carrie Lee, MD

919-966-0405carrie_lee@med.unc.edu

Principal Investigator:

Carrie Lee, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • next-generation sequencing (NGS)
  • expert review of NGS
  • precision oncology
  • precision oncology navigator
  • genome informed therapy (GIT)
  • biomarker-directed clinical trials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-07-14.