Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03860376
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2019-02-11
Brief Title:
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
Personalized Ex Vivo Drug Screening and Genomics Profiling to Guide Individualized Treatments for Children With Relapsed or Refractory Solid Tumors and Leukemias
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This study is a prospective non-randomized feasibility study Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing DST In addition genetic information will be obtained from cancer and normal germline tissue and correlated with drug response This study will provide the platform for informing treating physician about individualized treatment options The main outcome of this study will be the proportions of the patients whose treatment was guided by the personalized medicine approach
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 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 DST-guided therapy as compared to non-DST guided conventional therapy
EXPLORATORY OBJECTIVE To explore associations between genetic abnormalities in malignancies and ex vivo drug response
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 DST-guided therapy as compared to non-DST guided conventional therapy
EXPLORATORY OBJECTIVE To explore associations between genetic abnormalities in malignancies and ex vivo drug response
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 8LA05 | OTHER_GRANT | Florida Department of Health-Live Like Bella Foundation | None |