Advanced Cancer Clinical Trial
Official title:
Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | October 18, 2025 |
Est. primary completion date | October 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Bien-Willner Physicians Group PA | Carolina Blood and Cancer Care Associates, No One Left Alone |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Number of patients with reports placed on clinical trial | 2 years | ||
Secondary | Number of patients that get molecular genetic consults beyond the test interpretation | 2 years | ||
Secondary | Percent of patients getting targeted therapies | percentage of patients getting the correct targeted treatment identified by testing | 2 years | |
Secondary | Percent of eligible patients getting genomic testing | 2 years | ||
Secondary | Percent of eligible patients getting the correct test based on guidelines | 2 years |
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