Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791215
Status:
RECRUITING
Last Update Posted:
2023-06-09
First Post:
2021-03-08
Brief Title:
Circulating Tumor DNA Alterations in Non-small Cell Lung Cancer Patients Treated With Pembrolizumab
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
An Observational Study of Circulating Tumor DNA Genetic Alterations in Non-small Cell Lung Cancer Patients Treated With Pembrolizumab
Status:
RECRUITING
Status Verified Date:
2023-06
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:
The purpose of this study is to learn how to use blood tests to better predict how patients with non-small cell lung cancer who are taking pembrolizumab for cancer treatment will respond to treatment with pembrolizumab and to understand how the immune system and cancer interact
Tests will be performed on tumor tissue and blood samples and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment This is an observational study so participants will not receive cancer treatment other than the treatment received as standard of care
Tests will be performed on tumor tissue and blood samples and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment This is an observational study so participants will not receive cancer treatment other than the treatment received as standard of care
Detailed Description:
The primary and secondary endpoints of this study are to determine the kinetics of Circulating tumor DNA ctDNA as defined by a set of patient-specific tumor mutations The analysis will be undertaken using the Signatera Assay from Natera Circulating tumor DNA in plasma samples obtained over the course of pembrolizumab treatment will be assessed by high-intensity next-generation genetic sequencing to identify genomic alterations in genes The assay will target 16 defined patient specific mutations Data acquired will be analyzed to characterize the association between these genetic elements clinical response and durability of responses There will be prospective and retrospective groups for the study Samples will be collected from patients in the prospective cohort who have been treated with pembrolizumab monotherapy at Columbia University Irving Medical Center under standard of care treatment Subjects in the retrospective cohort will provide genetic data
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