Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer
Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer
1 other identifier
observational
560
1 country
1
Brief Summary
The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Shorter than P25 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
First Submitted
Initial submission to the registry
July 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 18, 2014
November 1, 2014
1 year
July 4, 2012
November 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging
up to 2.5 years (end of study, December 2014)
Eligibility Criteria
patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.
You may qualify if:
- Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion
You may not qualify if:
- patients had previously received neoadjuvant chemotherapy or chemoradiotherapy
- patients with obviously advanced gastric cancer by endoscopy
- the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sang Gyun Kim, M.D.
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
- PRINCIPAL INVESTIGATOR
Jeongmin Choi, M.D.
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor, Department of Internal Medicine and Liver Research Institute
Study Record Dates
First Submitted
July 4, 2012
First Posted
April 16, 2013
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 18, 2014
Record last verified: 2014-11