EDPO: Evaluating Disparities in Precision Oncology
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Compare Overall Survival between Black patients and White patients [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
- Compare rate of new onset therapy- induced peripheral neuropathy (TIPN) between Black patients and White patients [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Secondary Outcome Measures
- Compare efficacy based on duration on therapy (DOT) between between Black patients and White patients [From baseline to end of treatment (i.e. up to 2 years)]
- Assess the significance of genetic ancestry on overall survival [Baseline]
Using Illumina's Ex Platform to review genetic ancestry
- Assess the significance clinical demographics on overall survival [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
- Assess the significance of social determinants of health (SDoH) on overall survival [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Using questionnaires. Hazard ratios will be reported per 1 standard deviation unit for continuous SDoH predictors, which standardizes the interpretation by accounting for different measurement metrics.
- Assess the significance of tumor biology on overall survival [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Hazard ratios will be reported per 1 standard deviation unit for continuous tumor biology predictors (i.e. WES/WTS, plasma ctDNA and germline testing) , which standardizes the interpretation by accounting for different measurement metrics.
- Assess the significance of access to treatment on overall survival [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Hazard ratios will be reported per 1 standard deviation unit for continuous access to treatment predictors (i.e. distance to cancer care and insurance status) , which standardizes the interpretation by accounting for different measurement metrics.
- Assess the significance of clinical demographics on therapy-induced neuropathy [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
- Assess the significance of social determinants of health on on therapy-induced neuropathy [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Using questionnaires
- Assess the significance of tumor biology on therapy induced neuropathy [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Odds ratios will be reported per 1 standard deviation unit for continuous tumor biology predictors (i.e. WES/WTS, plasma ctDNA and germline testing), which standardizes the interpretation by accounting for different measurement metrics.
- Assess the significance of access to treatment on therapy-induced neuropathy [through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Odds ratios will be reported per 1 standard deviation unit for continuous access to treatment predictors (i.e. distance to cancer care and insurance status), which standardizes the interpretation by accounting for different measurement metrics.
- Compare relative dose intensity (RDI) of taxane therapy in Black versus White patients. [From baseline to end of treatment (i.e. up to 2 years)]
Measured by dose reductions or dose cessations attributed to therapy induced peripheral neuropathy from chart review
- Change in self-reported quality of life scale (EORTC-QLQ-30) between Black and White patients [From baseline to end of treatment (i.e. up to 2 years)]
to assess differences in the impact of neuropathy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability to provide written informed consent and HIPAA authorization
-
Subjects must be ≥ 18 years old at the time of consent
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Diagnosis of advanced or metastatic cancer and planning to undergo molecular testing as part of their routine cancer care
Exclusion Criteria:
N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Bryan P Schneider, MD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTO-IUSCCC-0819