Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830826
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2021-03-24
Brief Title:
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
A Prospective National Multi-center Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
This study is a prospective national multi-center non-interventional study The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups based on different EGFR mutation status and different clinical stages
Detailed Description:
About 2000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study and will be followed up to 2 years after enrollment according to the actual clinical situation The analysis method of this study is mainly based on descriptive statistics The information about the human genetic resources of the subjects to be collected includes demography physical examination WHO fitness status medical history smoking history disease characteristics surgical information initial and follow-up adjuvant treatment pattern laboratory tests survival status and adverse events related to gefitinibosimertinib serious adverse eventsnon-severe ADR measures taken for adverse events outcome of adverse events
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