Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06234579
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-04-10
Brief Title:
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC Galileo Project
Sponsor:
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
At the time of diagnosis all newly diagnosed ALK NSCLC patients eligible for first line treatment with alectinib or brigatinib or lorlatinib will be considered for the study
In case of progression a multidisciplinary team oncologists interventional pneumologists and radiologists surgeons will discuss case-by-case the feasibility to procure an adequate biopsy from progressing lesions Repeat biopsies will be performed within 2 weeks from multidisciplinary evaluation and before the start of subsequent treatment If repeat biopsies are not technically or safely feasible or fail to yield sufficient material for genomic analysis we will collect a whole blood drawn by venepuncture for the analysis of ctDNA
Enrollment Count:
108
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 103084 |
Who Masked List: