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Black patients with advanced cancer for Cancer (EDPO Trial)
N/A
Recruiting
Led By Bryan P Schneider, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Awards & highlights
EDPO Trial 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.
Eligible Conditions
- Cancer
EDPO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer
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
Secondary outcome measures
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
Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy
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
+7 moreEDPO Trial Design
2Treatment groups
Experimental Treatment
Group I: Non Black patients with advanced cancerExperimental Treatment1 Intervention
Group II: Black patients with advanced cancerExperimental Treatment1 Intervention
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
972,676 Total Patients Enrolled
Bryan P Schneider, MDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
677 Total Patients Enrolled
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