Metastatic CancerEDPONCT06081517
Evaluating Disparities in Precision Oncology
An observational study of Metastatic Cancer and Advanced Cancer, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Advanced Cancer
- What is being tested?
- Social Determinants of Health and toxicity questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10,600 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those with cancers being referred for molecular testing through their site's precision genomics program.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Maria McQuade, BA, (317) 278-5238, mcquadem@iu.edu
Bryan Schneider, MD
About this study
Official title: Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model
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.
Read the 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.
- Conditions
- Metastatic Cancer, Advanced Cancer
- Being tested
- Social Determinants of Health and toxicity questionnaires
- Keywords
- Precision Medicine, Disparities
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Determinants of Health and toxicity questionnairesBehavioural
Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Black patients with advanced cancer | Not described Receives: Behavioral: Social Determinants of Health and toxicity questionnaires | |
| Non Black patients with advanced cancer | Not described Receives: Behavioral: Social Determinants of Health and toxicity questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer
Measured: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
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
Measured: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary outcomes (10)
Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)
Measured: 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
Measured: Baseline
Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start26 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Schneider, Indiana University
- Investigators
- Bryan P Schneider, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081517
- Sponsor's protocol ID
- CTO-IUSCCC-0819
- Acronym
- EDPO
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model
- ClinicalTrials.gov ID
- NCT06081517
- Acronym / sponsor ID
- EDPO / CTO-IUSCCC-0819
- Conditions
- Metastatic Cancer, Advanced Cancer
- Keywords
- Precision Medicine, Disparities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,600 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black patients with advanced cancer | – | Behavioral: Social Determinants of Health and toxicity questionnaires |
| Non Black patients with advanced cancer | – | Behavioral: Social Determinants of Health and toxicity questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those with cancers being referred for molecular testing through their site's precision genomics program.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Determinants of Health and toxicity questionnairesCollect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes. | Behavioural | Black patients with advanced cancer, Non Black patients with advanced cancer |
Primary outcome
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
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
10 secondary outcomes
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)
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan P Schneider, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Advanced Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria McQuade, BA ((317) 278-5238, mcquadem@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.