Evaluating Disparities in Precision Oncology

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Cancer, Advanced Cancer

Intervention / Treatment
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* Behavioral: Social Determinants of Health and toxicity questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and HIPAA authorization Subjects must be ≥ 18 years old at the time of consent Diagnosis of advanced or metastatic cancer and planning to undergo molecular testing as part of their routine cancer care Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Black patients with advanced cancer<br> | Behavioral: Social Determinants of Health and toxicity questionnaires<br>* Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.<br>|
| Non Black patients with advanced cancer<br> | Behavioral: Social Determinants of Health and toxicity questionnaires<br>* Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Using Illumina's Ex Platform to review genetic ancestry | Baseline | 
| 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 | 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. | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| Assess the significance of tumor biology on overall survival | 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. | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| Assess the significance of access to treatment on overall survival | 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. | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| 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 | Using questionnaires | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| Assess the significance of tumor biology on therapy induced neuropathy | 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. | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| Assess the significance of access to treatment on therapy-induced neuropathy | 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. | through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years | 
| Compare relative dose intensity (RDI) of taxane therapy in Black versus White patients. | Measured by dose reductions or dose cessations attributed to therapy induced peripheral neuropathy from chart review | From baseline to end of treatment (i.e. up to 2 years) | 
| Change in self-reported quality of life scale (EORTC-QLQ-30) between Black and White patients | to assess differences in the impact of neuropathy | From baseline to end of treatment (i.e. up to 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precision Medicine, Disparities