Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443684
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
A Study of Molecular Residual Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Prospective Observational Study of Molecular Residual Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this prospective observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment The main question it aims to answer is
1 Whether MRDMinimal residual disease status can predict recurrence events in stage III driven-mutant NSCLC in advance
1 Whether MRDMinimal residual disease status can predict recurrence events in stage III driven-mutant NSCLC in advance
Detailed Description:
Non-small cell lung cancer in stage III IIIa IIIIb IIIc has a low survival rate and the 5-year survival rate of stage III patients is less than 30 In clinical studies of non-small cell lung cancer operable stage III driver gene mutations postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy
The tumor patients still have residual malignant tumor cells in vivo during or after treatment and minimal residual foci are released during cell necrosis or apoptosis Early the domestic large lung cancer MRDMinimal residual disease prospective research results for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population found that postoperative MRD negative population could not benefit from adjuvant therapy clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring and exploring the stage II III MRD turn high risk of postoperative lung cancer Therefore for nearly 70 of patients with driver gene-positive non-small-cell lung cancer detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrenceprogression
The tumor patients still have residual malignant tumor cells in vivo during or after treatment and minimal residual foci are released during cell necrosis or apoptosis Early the domestic large lung cancer MRDMinimal residual disease prospective research results for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population found that postoperative MRD negative population could not benefit from adjuvant therapy clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring and exploring the stage II III MRD turn high risk of postoperative lung cancer Therefore for nearly 70 of patients with driver gene-positive non-small-cell lung cancer detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrenceprogression
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