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Trial Title:
Evaluating Disparities in Precision Oncology
NCT ID:
NCT06081517
Condition:
Metastatic Cancer
Advanced Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Precision Medicine
Disparities
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Social Determinants of Health and toxicity questionnaires
Description:
Collect detailed clinical, and social data from patients to identify significant
contributors of disparate survival and toxicity outcomes.
Arm group label:
Black patients with advanced cancer
Arm group label:
Non Black patients with advanced cancer
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.
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.
Criteria for eligibility:
Study pop:
Those with metastatic cancers being referred for molecular testing through their site's
precision genomics program.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Austen Lax
Phone:
317-274-5288
Email:
laxa@iu.edu
Investigator:
Last name:
Bryan Schneider, MD
Email:
Principal Investigator
Start date:
January 26, 2024
Completion date:
July 2029
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081517
