Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05116618
Status:
WITHDRAWN
Last Update Posted:
2022-09-21
First Post:
2021-11-01
Brief Title:
Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant ALK- and ROS1-rearranged
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant ALK- and ROS1-rearranged Non-small Cell Lung Cancer Patients With Central Nervous System CNS Progression After Evidence of Prior CNS Benefit on Relevant Tyrosine Kinase Inhibitors
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cancelled by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid CSF for patients with CNS progression with or without extra-CNS eCNS progression and concordance with plasmatissue
Detailed Description:
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid CSF for patients with CNS progression with or without extra-CNS eCNS progression and concordance with plasmatissue
For each individual patient with CNS progression with or without eCNS progression compare the molecular status primary oncogene detection and any mechanisms of identifiable resistance including EGFR- ALK- and ROS1-mutations ALK-amplification and bypass-tracks activating mutations of CSF plasma and CNS tissue if data from pathology report is available
Molecular status will also be compared with previously obtained and stored plasmatissue prior to the initiation of current next-generation tyrosine-kinase inhibitor TKI
For each individual patient with CNS progression with or without eCNS progression compare the molecular status primary oncogene detection and any mechanisms of identifiable resistance including EGFR- ALK- and ROS1-mutations ALK-amplification and bypass-tracks activating mutations of CSF plasma and CNS tissue if data from pathology report is available
Molecular status will also be compared with previously obtained and stored plasmatissue prior to the initiation of current next-generation tyrosine-kinase inhibitor TKI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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