Evaluating Disparities in Precision Oncology

Metastatic Cancer Clinical Trial

— EDPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081517
• Other study ID #: CTO-IUSCCC-0819
• Status: Recruiting
• Start date: January 26, 2024
• Est. completion date: July 2029

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Lina Sego, BA
• Phone: 317-278-5624
• Email: lmsego[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10600
• Est. completion date: July 2029
• Est. primary completion date: July 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Diagnosis of advanced or metastatic cancer and planning to undergo molecular testing as part of their routine cancer care

4. Patients who self-report race as Black or patients who self-report as White

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Behavioral:
• Social Determinants of Health and toxicity questionnaires
Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.

Locations

Country	Name	City	State
United States	Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Primary	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		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)		From baseline to end of treatment (i.e. up to 2 years)
Secondary	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		Baseline
Secondary	Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	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		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	Compare the rate of checkpoint inhibitor -induced immune -related adverse events (irAEs) between White and Black patients		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	Compare the rate of drug -induced hypertension between White and Black patients		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	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		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years
Secondary	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		through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years