Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708639
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-02-02
First Post:
2021-01-12
Brief Title:
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-01
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:
MonAlec
Brief Summary:
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment
Detailed Description:
The purpose and objectives of the non-interventional study with primary data collection is
To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect
To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib
To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression
To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect
To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib
To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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