PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Recruiting
N/AInterventional Study
Solid Tumor MalignanciesMetastatic CancerBreast CancerColorectal CancerLung CancerBladder Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with stage IV solid tumors like breast, lung, colorectal, or bladder cancer. Participants will receive support in understanding their genetic test results for better treatment options.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with stage IV solid tumor malignancy.
I have given written consent to participate.
My doctor thinks genetic testing is appropriate for my treatment.
I have not had a genomic tumor test ordered, or the test was ordered but the results are not available.
I am able to follow study procedures as determined by my doctor.
I have an ECOG or Karnofsky Performance Status of 0-2.
You may not be able to join if
I have an active cancer in addition to my solid tumor malignancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 n…
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.
Trial Locations
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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 co…
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.
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