Precision Oncology for Cancer
(PROGRESS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCarrie Lee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for stage IV solid tumor cancer patients, including those with breast, lung, colorectal, and bladder cancers. Participants must be eligible for genomic testing to guide therapy choices.

Inclusion Criteria

Subjects willing and able to comply with study procedures based on the judgment of the investigator

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

See 4 more

Exclusion Criteria

I have another active cancer besides the one being studied.

Treatment Details

Interventions

Precision Oncology Navigation (Precision Medicine)

Trial OverviewThe study tests if a precision oncology navigator and expert review of next-generation sequencing (NGS) results can increase the use of genome-informed therapies in advanced cancer treatment over historical rates.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: The potential candidates for genome-informed targeted therapyExperimental Treatment3 Interventions

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.