Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03926260
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2019-04-16
Brief Title:
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
Sponsor:
Centre Hospitalier Departemental Vendee
Organization:
Centre Hospitalier Departemental Vendee
Study Overview
Official Title:
Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers
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:
ELUCID
Brief Summary:
In patients with locally advanced or metastatic tumors first-line therapeutic management is based on the use of targeted therapies EGFR BRAF ALK and ROS1 inhibitors immunotherapies anti-PD1 anti-PDL1-antibodies or chemotherapy
Despite patient selection based on histo-pathological and molecular criteria not all patients respond to treatment There are currently no markers to definitively guarantee a patients response
An alternative is to identify early patient response to treatment The investigator hypothesize that change in circulating tumor DNA concentration ctDNA allow to early identify patients therapeutic response and non-response of patients regardless of the type of treatment used in the first line setting
Despite patient selection based on histo-pathological and molecular criteria not all patients respond to treatment There are currently no markers to definitively guarantee a patients response
An alternative is to identify early patient response to treatment The investigator hypothesize that change in circulating tumor DNA concentration ctDNA allow to early identify patients therapeutic response and non-response of patients regardless of the type of treatment used in the first line setting
Detailed Description:
The primary objective is to determine whether early evolution between baseline and week 3 of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients regardless of treatment
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?:
None
Is an FDA AA801 Violation?:
None