Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-29 @ 3:32 PM
Study NCT ID:
NCT06023966
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery
Status:
COMPLETED
Status Verified Date:
2023-08
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:
A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.
Detailed Description:
The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).
Study Oversight
Has Oversight DMC:
False
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?: