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

NCT06090513 | Not Yet Recruiting

• 1 other identifier: 2230817
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Advanced Cancer; Solid Tumor, Adult; Myeloid Malignancy

Keywords

Comprehensive genomic profile; molecular genetic pathology; community cancer center; healthcare disparities; precision medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Number of patients with reports with actionable results

  2 years

• Number of patients with reports placed on clinical trial

  2 years

• Number of patients that get molecular genetic consults beyond the test interpretation

  2 years

• Percent of patients getting targeted therapies

  2 years

• Percent of eligible patients getting genomic testing

  2 years

Study Arms (2)

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.

Diagnostic Test: limited genetic testing or no testing

Test group

Same patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support.

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

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)

Test group

limited genetic testing or no testing DIAGNOSTIC_TEST

Minimal genetic testing for eligible patients or treatment without testing

Control/Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers at a community cancer outpatient clinic or hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bien-Willner Physicians Group PA: lead
• No One Left Alone: collaborator
• Carolina Blood and Cancer Care Associates: collaborator

Study Sites (1)

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed, paraffin-embedded tumor material for clinical testing, extracted DNA and RNA

Study Officials

• Gabriel A Bien-Willner, MD, PhD

  Bien-Willner Physicians Grp PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haydee Diaz, MBASCP

CONTACT

3468310189; haydee@bwpgprecisionmed.com

Lenee Bien-Willner, MS

CONTACT

7138578748; lbwillner@bwpgprecisionmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: October 18, 2024
• Primary Completion: October 18, 2025
• Study Completion (Estimated): October 18, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)