Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857969
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-05-05
Brief Title:
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
Adopting a Functional Precision Medicine Approach to Reduce Cancer Disparities in Hispanic and Black Children of Miami
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional precision medicine FPM is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing DST and genomic profiling to determine the optimal individualized therapy for cancer patients In this study we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area which is 69 Hispanic and 18 Black Tumor cells collected from tissue taken during routine biopsy or surgery will be tested
Detailed Description:
PRIMARY OBJECTIVE The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on Functional Precision Medicine FPM the combination of ex vivo drug sensitivity testing DST and genomic profiling
SECONDARY OBJECTIVE The secondary objective of the study is to compare individual outcomes response and disease-free survival in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided conventional therapy
EXPLORATORY OBJECTIVE To explore associations between tumor molecular characteristics genomic and transcriptomic variation and ex vivo drug response with respect to patient ethnicity
SECONDARY OBJECTIVE The secondary objective of the study is to compare individual outcomes response and disease-free survival in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided conventional therapy
EXPLORATORY OBJECTIVE To explore associations between tumor molecular characteristics genomic and transcriptomic variation and ex vivo drug response with respect to patient ethnicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2U54MD012393-06 | NIH | None | httpsreporternihgovquickSearch2U54MD012393-06 |