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:
* How much leakage occurs in the use of precision medicine in the community setting? * Can we reduce leakage by providing access to better tools and services typically found in the academic medical centers? Participants will not be directly impacted and will receive standard of care. Measurements will be made of how often physicians select the appropriate test for patients, and how often they select the most appropriate therapy for their patients before and after the implementation of tools created to reduce leakage.
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.
newly diagnosed or change in status Advanced Cancer patient (recurrent, refractory, metastatic, or high grade)
Cancer patient for whom genomic testing (comprehensive genomic profile (CGP)) is recommended by relevant guidelines
Patient does not seek additional treatment
Patient younger than 18 years
Treatment provided at a tertiary medical center
CGP testing already performed and there is no change in patient cancer status
All comers at a community cancer outpatient clinic or hospital
Cohort
Prospective
Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation
Combination productTSO500; 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)
limited genetic testing or no testing
Diagnostic testMinimal genetic testing for eligible patients or treatment without testing
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
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.
Number of patients with reports with actionable results
defined as 1: FDA-approved targeted therapy on indication; 2- recommendation on non-FDA approved indication
Number of patients with reports placed on clinical trial
Number of patients that get molecular genetic consults beyond the test interpretation
Percent of patients getting targeted therapies
percentage of patients getting the correct targeted treatment identified by testing
Click on the lead sponsor to view all of their trials.
Bien-Willner Physicians Group PA
Lead sponsor
No One Left Alone
Collaborator
Carolina Blood and Cancer Care Associates
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
