Health TrialsbyHealthPanel

Evaluating Disparities in Precision Oncology

ConditionsMetastatic CancerAdvanced Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Those with cancers being referred for molecular testing through their site's precision genomics program.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

10,600 Participants
are divided into 2 treatment groups
Group A: Black patients with advanced cancer1 intervention
Group B: Non Black patients with advanced cancer1 intervention

Trial 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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