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

Part of paid clinical trials in Rock Hill, South Carolina.

Sponsor
Bien-Willner Physicians Group PA
Study ID
NCT06090513
Status
Not Yet Recruiting

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Conditions

  • Advanced Cancer
  • Myeloid Malignancy
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)
  • limited genetic testing or no testing — DIAGNOSTIC_TEST
    Minimal genetic testing for eligible patients or treatment without testing

Study Details

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.

Key Dates

Start date
Oct 18, 2024
Status verified
Aug 2024
Primary completion
Oct 18, 2025
Completion
Oct 18, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Test group
    Same patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support.

Primary Outcome Measure

Percentage of eligible patients getting the correct genetic test-informed treatment [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolina Blood and Cancer Care AssociatesRock HillSouth Carolina29732
Niyati Nathwani, MD
[email protected]
803-329-7772

Find similar trials in Rock Hill, SC

By research site
Carolina Blood and Cancer Care Associates· Rock Hill, SC

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