PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06896162
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Expert Review — OTHER
    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. — OTHER
    Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
  • The Precision Oncology Navigation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 27, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center, University of North CarolinaChapel HillNorth Carolina27599
Carrie Lee, MD
[email protected]
919-966-0405
Carrie Lee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Bladder cancerBreast cancerColorectal cancerLung cancer
By specialty
OncologyUrologyBreast oncologyWomen's healthGI oncologyLung oncologyLung disease
By research site
Lineberger Comprehensive Cancer Center, University of North Carolina· Chapel Hill, NC

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