Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03236675
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2016-02-24
Brief Title:
Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Sponsor:
Exosome Diagnostics Inc
Organization:
Exosome Diagnostics Inc
Study Overview
Official Title:
Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer NSCLS patients
Detailed Description:
The goal of this study is two-fold 1 Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis using an institutionally accepted assay 2 Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis using an institutionally accepted assay
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