Department of Gastric Surgery
Fuzhou, Fujian, China
NCT Number: NCT05465993
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.
Looking for future studies?
Notify MeAll sexes
Observational
Fuzhou, Fujian, China
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years
distant, peritoneal, and local recurrence
Time frame: 5 years
A hypothetical cohort of 1000 GC patients was generated to compare the effectiveness of surveillance among the above-mentioned strategies by calculating the sum of the delayed detection months. Delayed detection months were defined as the duration from the occurrence of failure to the next-nearest follow-up. For instance, if a patient develops distant metastasis in the 3rd month while the next nearest planned visit is in the 5th month, the delayed -detection time for this patient is 2 months. The total number of delayed detection months of our risk-based surveillance schedule and that of the control strategies were simulated and compared.
Time frame: 5 years
incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in cost by the difference in QALY.
Fujian Medical University
Other
An International Multi-institution Real-world Study of the Optimal Surveillance Frequency for Stage II/III Gastric Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00183898
Digestive System Diseases, Digestive System Neoplasms
Los Angeles, California, United States
View Trial DetailsNCT00342654
Digestive System Diseases, Digestive System Neoplasms
Beijing, China
View Trial DetailsNCT05396300
Colonic Diseases, Colorectal Cancer
Hangzhou, Zhejiang, China
View Trial DetailsNCT05538195
Colon Cancer, Colonic Diseases
Henan, China
View Trial Details