the Optimal Surveillance Frequency for Stage II/III Gastric Cancer
An International Multi-institution Real-world Study of the Optimal Surveillance Frequency for Stage II/III Gastric Cancer
1 other identifier
observational
2,311
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedFirst Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedJuly 20, 2022
July 1, 2022
2.3 years
July 18, 2022
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence rate
distant, peritoneal, and local recurrence
5 years
Secondary Outcomes (2)
Delayed-detection months
5 years
Incremental cost-effectiveness ratios (ICERs)
5 years
Eligibility Criteria
A total of 1,661 stage II/III GC patients 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.
You may qualify if:
- (1) Eastern Cooperative Oncology Group (ECOG) scores of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory); (2) pathologically confirmed AGC (pStage II and III, except pT4b); (3) no distant metastasis or invasion of adjacent organs (e.g., pancreas, spleen, liver, and colon) detected intra- or post-operatively; and (4) D2 lymph node dissection of gastric cancer.
You may not qualify if:
- (1) American Society of Anesthesiologists (ASA) grade \>2; (2) remnant gastric or neuroendocrine cancer; (3) history of neoadjuvant chemotherapy; (4) palliative surgery; and (5) death within 30 days after surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastric Surgery
Fuzhou, Fujian, China
Related Publications (1)
Wu D, Lu J, Lin J, Xu BB, Xue Z, Zheng HL, Lin GS, Huang JB, Shen LL, Zheng CH, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Ma YB, Truty MJ, Huang CM. An international multi-institution real-world study of the optimal surveillance frequency for stage II/III gastric cancer: the more, the better? Int J Surg. 2023 Dec 1;109(12):4101-4112. doi: 10.1097/JS9.0000000000000731.
PMID: 37800589DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changming Huang, MD
Fujian Medical University Union Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of gastric surgery
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 20, 2022
Study Start
July 1, 2017
Primary Completion
October 1, 2019
Study Completion
July 15, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07