Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06081270
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-09-06
Brief Title:
Prospective Study on Resistance-associated Mutations in Metastatic Lung Cancer
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
Prospective Study on Resistance-associated Mutations in Metastatic Lung Neoplasm Patients With Alterations in Driver Oncogenes Except EGFR Undergoing Treatment With Specific Inhibitors
Status:
RECRUITING
Status Verified Date:
2023-10
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:
MUT-ONC
Brief Summary:
This single-centre prospective study is aimed at analysing by means of liquid biopsy with next generation sequencing analysis on circulating tumor DNA resistance mutations arising during therapy with selective inhibitors in patients with RTK-positive NSCLC or with mutations in the RasMAPK mitogen-activated protein kinase pathway treated at the San Gerardo Hospital Monza
Detailed Description:
Non-small-cell lung cancer NSCLC is a heterogeneous disease that may have several genetic alterations in oncogenes responsible for progression 30-40 of NSCLC patients carry mutations affecting the RasMAPK pathway while alterations in receptor tyrosine kinases RTKs are found in approximately 25-35 of cases More than half of the latter are in the Epithelial Growth Factor Receptor EGFR gene and have been extensively studied In the remaining cases several genes are involved each with lower frequencies ranging from around 1 to 5 depending on the studies Despite the wide availability of inhibitors progression remains inevitable due to the emergence of drug resistance mechanisms The mechanisms by which resistance can be established are essentially of three types amplification of the target gene activation of other signal translation pathways by-pass track and the occurrence of mutations in the tyrosine kinase domain of the target protein Liquid biopsy with circulating tumour DNA ctDNA analysis provides a non-invasive surrogate method to identify somatic mutations by means of a simple blood sample without risk to the patient Moreover liquid biopsy by collecting ctDNA from different metastatic sites could better reflect tumour heterogeneity both spatial and temporal and could therefore constitute a simple method of longitudinal monitoring during treatment possibly making it possible to identify relapse early before clinical manifestation This single-centre prospective study is aimed at analysing by means of liquid biopsy with next generation sequencing analysis on ctDNA resistance mutations arising during therapy with selective inhibitors in patients with RTK-positive NSCLC or with mutations in the RasMAPK pathway treated at the San Gerardo Hospital Monza
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