Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients

Advanced Cancer Clinical Trial

Official title:

Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090513
• Other study ID #: 2230817
• Status: Not yet recruiting
• Start date: October 18, 2023
• Est. completion date: October 18, 2025

Study information

• Verified date: October 2023
• Source: Bien-Willner Physicians Group PA
• Contact: Haydee Diaz, MBASCP
• Phone: 3468310189
• Email: haydee[@]bwpgprecisionmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• Molecular Genetic Pathology expertise for tumor boards and case support

• Access to a best-in-class molecular test (TSO500)

• A software solution to improve data access between the clinic and lab (EMR-Lab Integration Application, ELIA) that was especially designed to reduce leakage in the community cancer care setting.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Myeloid Malignancy
• Neoplasms
• Solid Tumor, Adult

Intervention

Combination Product:
• Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation
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)

Diagnostic Test:
• limited genetic testing or no testing
Minimal genetic testing for eligible patients or treatment without testing

Locations

Country	Name	City	State
United States	Carolina Blood and Cancer Care Associates	Rock Hill	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Bien-Willner Physicians Group PA	Carolina Blood and Cancer Care Associates, No One Left Alone

Country where clinical trial is conducted

United States, 

Outcome

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