Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Indiana University
- Enrollment
- 10,600
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to provide written informed consent and HIPAA authorization
- •Patients must be ≥ 18 years old at the time of consent
- •Patients who have or are planning to undergo molecular testing as part of their routine cancer care
Exclusion Criteria
- Not provided
Arms & Interventions
Non Black patients with advanced cancer
Intervention: Social Determinants of Health and toxicity questionnaires (Behavioral)
Black patients with advanced cancer
Intervention: Social Determinants of Health and toxicity questionnaires (Behavioral)
Outcomes
Primary Outcomes
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
Time Frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer
Time Frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary Outcomes
- 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)
- 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)
- 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 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 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)
- 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 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)
Investigators
Bryan Schneider
Assistant Professor of Clinical Medicine
Indiana University