Clinical trial NCT06081517: Evaluating Disparities in Precision Oncology
Official title: Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Cancer
Advanced Cancer
Keywords: Precision Medicine
Disparities
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 10600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with cancers being referred for molecular testing through their site's precision genomics program.

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.

Eligibility criteria: 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 planning to undergo molecular testing as part of their routine cancer care

Exclusion Criteria:

N/A

Primary outcomes:
measure: Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: 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
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary outcomes:
measure: Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)
timeFrame: From baseline to end of treatment (i.e. up to 2 years)
measure: 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
timeFrame: Baseline
measure: Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: 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
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: Compare the rate of checkpoint inhibitor -induced immune -related adverse events (irAEs) between White and Black patients
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: Compare the rate of drug -induced hypertension between White and Black patients
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: 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
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
measure: 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
timeFrame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Bryan P Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: