Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394037
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-27
Brief Title:
Active Surveillance for Ground-glass Opacities
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Active Surveillance for Patients with Ground-glass Opacities a Single-arm Multi-center Phase III Trial ECTOP-1028
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study is a single-arm multi-center phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project ECTOP The primary objective of the study is to assess the overall survival of patients with single ground-glass opacities by employing an active surveillance approach rather than opting for surgical resection
Detailed Description:
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection potentially allowing many of these patients to avoid surgery altogether Surgical criteria are met if any of the lesions exhibit progression
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