Evaluating Disparities in Precision Oncology (EDPO)

Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model

This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Behavioral: Social Determinants of Health and toxicity questionnaires

Detailed Description

This study proposes an innovative approach leveraging the molecular tumor boards across four comprehensive cancer centers, where real- world, diverse patients with metastatic cancer are seen receiving a broad scope of therapies in the context of precision medicine. The study plans to collect detailed clinical, social, and genomic data from patients to identify significant contributors of disparate survival and toxicity outcomes for patients with metastatic cancer.

• Study Type: Observational
• Enrollment (Estimated): 10600

Contacts and Locations

• Study Contact: Name: Bryan P Schneider, MD; Phone Number: 317-948-3855; Email: bpschnei@iu.edu
• Study Contact Backup: Name: Maria McQuade, BA; Phone Number: (317) 278-5238; Email: mcquadem@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
      • Principal Investigator: Bryan Schneider, MD
      • Contact: Maria McQuade, BA; Phone Number: (317) 278-5238; Email: mcquadem@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Those with cancers being referred for molecular testing through their site's precision genomics program.

Description

Inclusion Criteria:

1. Ability to provide written informed consent and HIPAA authorization
2. Patients must be ≥ 18 years old at the time of consent
3. Patients who have or are planning to undergo molecular testing as part of their routine cancer care

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Black patients with advanced cancer	Behavioral: Social Determinants of Health and toxicity questionnaires; Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.
Non Black patients with advanced cancer	Behavioral: Social Determinants of Health and toxicity questionnaires; Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare rate of new onset or worsening therapy- induced peripheral neuropathy (TIPN) between Black patients and White patients with advanced cancer prospectively exposed to a taxane	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)	From baseline to end of treatment (i.e. up to 2 years)
Assess the significance of key attributes (tumor genomics, clinical demographics, SDoH, access, and the intersection of tumor biology and drug impact) on efficacy, and survival outcomes	Baseline
Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Assess the impact of toxicity as measured by dose reductions or dose cessations attributed to TIPN from chart review measured as RDI, a function of the ratio of received to intended doses, and thus accounts for differences in drugs or time of therapy	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare the rate of checkpoint inhibitor -induced immune -related adverse events (irAEs) between White and Black patients	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare the rate of drug -induced hypertension between White and Black patients	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare utility of precision genomic information defined by the percentage of patients receiving results, screened for or enrolled on a genomically-directed clinical trial, and receiving a targeted therapy between White and Black patients	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare the differences in prevalence of level 1/2 actionable mutations, prior lines of therapy, receipt of a genomically matched therapy and receipt of an FDA-approved drug between Black and White patients	through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Bryan P Schneider, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Disparities; Precision Medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Population Characteristics; Health Status; Demography; Health; Social Determinants of Health
• Other Study ID Numbers: CTO-IUSCCC-0819

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No