Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-30 @ 12:49 AM
Study NCT ID:
NCT05441566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-07-01
First Post:
2022-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Significance of MRD After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
Sponsor:
Shenzhen People's Hospital
Organization:
Study Overview
Official Title:
Dynamic Monitoring and Significance of Molecular Residual Disease After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
1\. It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Therefore, the first key scientific issue to be solved in this topic is to analyze the correlation between MRD detection results and both recurrence and adjuvant therapy efficacy by focusing on the stage IB-IIA postoperative NSCLC patient population. To provide clinical data to aid clinical screening of NSCLC patients at high risk of recurrence after surgery in stage IB-IIA.
2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.
3\. If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.
2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.
3\. If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.
Detailed Description:
None
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?: