Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-03 @ 4:46 PM
Study NCT ID:
NCT05465993
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Optimal Surveillance Frequency for Stage II/III Gastric Cancer
Sponsor:
Fujian Medical University
Organization:
Study Overview
Official Title:
An International Multi-institution Real-world Study of the Optimal Surveillance Frequency for Stage II/III Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2022-07
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:
Due to lacking of evidence on surveillance for gastric cancer (GC), this study aimed to determine the optimal postsurgical surveillance strategy for stage II/III GC patients and compare its cost-effectiveness with traditional surveillance strategies.
Detailed Description:
Background The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postsurgical surveillance for all stage II/III GC patients. Additionally, In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with stage II/III GC remains unclear.
Methods Prospectively collected data from stage II/III GC patients (n=1,661) who underwent gastrectomy at Fujian Medical University Union Hospital (FJMUUH) between January 2010 and October 2015. For external validation, two independent cohorts were included, which were composed of 380 stage II/III GC patients who underwent gastrectomy at the Mayo Clinic between July 1991 and July 2012 and 270 stage II/III GC patients at the Qinghai university affiliated hospital (QUAH) between May 2010 and Oct 2014. Random survival forest models were used to predict dynamic recurrence hazards and to construct individual surveillance strategies for stage II/III GC. Cost-effectiveness were assessed by Markov model.
Methods Prospectively collected data from stage II/III GC patients (n=1,661) who underwent gastrectomy at Fujian Medical University Union Hospital (FJMUUH) between January 2010 and October 2015. For external validation, two independent cohorts were included, which were composed of 380 stage II/III GC patients who underwent gastrectomy at the Mayo Clinic between July 1991 and July 2012 and 270 stage II/III GC patients at the Qinghai university affiliated hospital (QUAH) between May 2010 and Oct 2014. Random survival forest models were used to predict dynamic recurrence hazards and to construct individual surveillance strategies for stage II/III GC. Cost-effectiveness were assessed by Markov model.
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?: