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NCT Number: NCT06081517

Evaluating Disparities in Precision Oncology

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.

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Key information

Conditions

Metastatic Cancer Advanced Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

N/A

Treatment and study plan

Social Determinants of Health and toxicity questionnaires

Behavioral

Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)

    Time frame: From baseline to end of treatment (i.e. up to 2 years)

  2. 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

    Time frame: Baseline

  3. Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  4. 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

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  5. Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  6. Compare the rate of checkpoint inhibitor -induced immune -related adverse events (irAEs) between White and Black patients

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  7. Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  8. Compare the rate of drug -induced hypertension between White and Black patients

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  9. 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

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  10. 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

    Time frame: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: EDPO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 13, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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