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

NCT06090513 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • No One Left Alone

    collaborator UNKNOWN

  • Carolina Blood and Cancer Care Associates

    collaborator UNKNOWN

  • Bien-Willner Physicians Group PA

    lead OTHER

Principal Investigators

  • Gabriel A Bien-Willner, MD, PhD · Bien-Willner Physicians Grp PA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2025-10-18
Completion
2026-10-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090513 on ClinicalTrials.gov