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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081517
Other study ID # CTO-IUSCCC-0819
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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