Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02140463
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2014-02-10
Brief Title:
Next Generation pErsonalized tXTherapy With Plasma DNA Trial-2 in Refractory Solid Tumors The NEXT-2 Trial
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Next Generation pErsonalized tXTherapy With Plasma DNA Trial-2 in Refractory Solid Tumors The NEXT-2 Trial
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Analysis of cell free DNAcfDNA unlike tissue biopsy presents a new tool for the monitoring and treatment of cancer The investigators have developed a differentiated sequencing assay Digital Sequencing Technology DST that enables detection of rare genomic abnormalities with ultra high-specificity and sensitivity The investigators assay is able to eliminate the error and distortion created by sample-prep and sequencing processes in standard NGSnext-generation sequencing workflows and produce near-perfect representations of all rare variants
The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 01 cancer cell line titration samples standard Illumina SBSsequencing by synthesis generates many high-quality false positive variant calls in the range of 005-5 while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel
This work indicates the remarkable potential of using the investigators assay in deep analysis of cfDNA thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body
The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 01 cancer cell line titration samples standard Illumina SBSsequencing by synthesis generates many high-quality false positive variant calls in the range of 005-5 while the investigators assay resulted in highly sensitive and completely error-free variant calls across the entire panel
This work indicates the remarkable potential of using the investigators assay in deep analysis of cfDNA thereby allowing researchers and clinicians to comprehensively and non-invasively monitor the genetic dimension of cancer throughout the body
Detailed Description:
Same as above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None