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| Name | Class |
|---|---|
| No One Left Alone | UNKNOWN |
| Carolina Blood and Cancer Care Associates | UNKNOWN |
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The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). It has been observed that there are healthcare disparities in the community setting compared to academic medical centers, particularly in the use of precision medicine. The main questions the study aims to answer are:
We hope to reduce leakage in with the use of advanced tools and services, and use this study as a model to improve healthcare in the community cancer setting.
Precision Medicine in oncology requires the application of molecular diagnostic reporting to inform clinical decision making. However, its implementation has been slow and inefficient. Recent studies have demonstrated that contrary to new established standards of care and guidelines, eligible patients are often not getting the appropriate testing and test results are not being used appropriately to identify optimal therapies. This is especially true in the community oncology setting, resulting in healthcare disparities.
The investigators believe that the lack of efficiency and adoption of precision medicine is caused by "leakage" in the process of deploying genomic testing and reporting. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). Evidence suggests that leakage occurs at many steps of the process, and it is much more common in the community setting. A great deal of leakage occurs in the handling of ordering, retrieving, and tracking of external testing for necessary molecular diagnostic tests, the lack of integration between ordering facility and the laboratory, and a lack of expertise with understanding the complex reports.
This study aims to supply a community oncology practice with expertise, best-in-class testing, and integrative solutions to try to reduce leakage and reduce care disparities between the community clinic and large academic cancer centers.
This study will include a retrospective component, where the investigators will measure leakage (a predefined series of metrics)at a community cancer center over a six month period.
The investigators will then deploy a series of tools and services, including:
These services will be implemented for at least one year. The investigators will then remeasure the metrics over a year and see if there is a decrease in leakage.
It is expected that the deployment of expertise, improved testing, and improved data access and communication will reduce leakage and lead to improved patient care and outcomes. It is hoped that this will serve as a model to decrease healthcare disparities in cancer patients in the community setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control/Standard | Standard patient group: advanced cancer patients receiving limited and acceptable care without access to advanced genetic testing tools or expertise; patients at facility prior to deployment of TSO500, ELIA, and molecular tumor boards. |
| |
| Test group | Same patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation | Combination Product | TSO500; detect single nucleotide variants (SNV), INDELs, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutation burden (TMB) in eligible patients; ELIA software to interface clinic EMR to lab; Consultations and molecular tumor boards by molecular genetic pathologist (MGP) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eligible patients getting the correct genetic test-informed treatment | Demonstration that deployment of SOC services and ELIA improves % of eligible patients placed on appropriate targeted therapies according to guidelines | 2 years |
| Service turn-around-time | Demonstration that standard-of-care services and ELIA improves turnaround times for getting actionable results, allowing physicians to make timely decisions. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with reports with actionable results | defined as 1: FDA-approved targeted therapy on indication; 2- recommendation on non-FDA approved indication | 2 years |
| Number of patients with reports placed on clinical trial |
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Inclusion Criteria:
Exclusion Criteria:
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All comers at a community cancer outpatient clinic or hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haydee Diaz, MBASCP | Contact | 3468310189 | haydee@bwpgprecisionmed.com | |
| Lenee Bien-Willner, MS | Contact | 7138578748 | lbwillner@bwpgprecisionmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel A Bien-Willner, MD, PhD | Bien-Willner Physicians Grp PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | 29732 | United States |
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Formalin-fixed, paraffin-embedded tumor material for clinical testing, extracted DNA and RNA
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| limited genetic testing or no testing | Diagnostic Test | Minimal genetic testing for eligible patients or treatment without testing |
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| 2 years |
| Number of patients that get molecular genetic consults beyond the test interpretation | 2 years |
| Percent of patients getting targeted therapies | percentage of patients getting the correct targeted treatment identified by testing | 2 years |
| Percent of eligible patients getting genomic testing | 2 years |
| Percent of eligible patients getting the correct test based on guidelines | 2 years |