Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04956198
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2021-06-25
Brief Title:
Drug Sensitivity and Mutation Profiling
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
Drug Sensitivity Testing and Mutation Profiling in Childhood Sarcomas
Status:
COMPLETED
Status Verified Date:
2023-02
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 observational study Freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing DST In addition the genetic profile of the tumor will be obtained from the medical records and correlated with drug response
Detailed Description:
The excised tumors or a biopsy will be interrogated for sensitivity or resistance to FDA-approved andor available investigational agents In addition normal samples blood or buccal swab will be collected for genetic analysis of germline mutations and cancer predisposition markers The timeframe between the sample acquisition and ex vivo DST results return will be approximately 5-10 working days All drugs tested in the DST assay will be assigned a hybrid score reflecting the tumors sensitivity and drug toxicity
This is an observational study and not a treatment protocol It will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes response survival or relapse The treating physician will decide which of the standard treatment options is appropriate independent of the DST results The results of DST will not be available to the treating physician at the time of decision on the treatment regimen DST will include all drugs from the standard treatment regimens available for all types of sarcomas
This is an observational study and not a treatment protocol It will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes response survival or relapse The treating physician will decide which of the standard treatment options is appropriate independent of the DST results The results of DST will not be available to the treating physician at the time of decision on the treatment regimen DST will include all drugs from the standard treatment regimens available for all types of sarcomas
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