Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493448
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-22
Brief Title:
Prospective Observational Cohort Study
Sponsor:
Lin Chen
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases a Multi-centre Noninterventional Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 observational study is to learn about the overall disease status diagnostic and therapeutic modalities and prognosis of patients with gastric cancer liver metastasisGCLM in China The investigators divided the participants into three groups three types of gastric cancer liver metastasis based onChinese c-GCLM classification systemThe main question it aims to answer is
1 How long do patients with GCLM live
2 How different treatment modalities surgery chemotherapy immunotherapy targeted therapy and others affect patients prognosis of three type All participants will be tracked for their physical condition
1 How long do patients with GCLM live
2 How different treatment modalities surgery chemotherapy immunotherapy targeted therapy and others affect patients prognosis of three type All participants will be tracked for their physical condition
Detailed Description:
This is a prospective non-interventional observational multi-centre real-world study designed to monitor the general condition treatment pattern and prognosis of patients with GCLM GCLM patients were divided into 3 types Type I resectable type Type II potentially resectable type Type III unresectable type The patients general information past medical history imaging results laboratory tests surgical and systemic therapy details will be recorded and analysed The 2-year overall survival OS will be recorded as the primary endpoint The different therapies surgery chemotherapy and immunotherapy of GCLM the effects of different therapies on prognosis including OS of type I II and III R0 resection rate and diease free survival DFS of type I successful conversion rate and R0 resection rate and events free survival EFS of type II will be recorded as secondary endpoints
This study involving human participants were reviewed and approved by the Ethics Committee of Chinese PLA General Hospital NoS2023-724-02 and will be conducted according to the guidelines of the Declaration of Helsinki Study findings will be disseminated through international peer-reviewed journal articles as well as public academic presentations at national and international conferences
This study involving human participants were reviewed and approved by the Ethics Committee of Chinese PLA General Hospital NoS2023-724-02 and will be conducted according to the guidelines of the Declaration of Helsinki Study findings will be disseminated through international peer-reviewed journal articles as well as public academic presentations at national and international conferences
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