UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005871 |
|---|---|
| Receipt number | R000006826 |
| Scientific Title | Japanese multicenter prospective cohort study of endoscopic resection for early gastric cancer using Web registry |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2022/08/24 20:03:42 |
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Basic information
Public title
Japanese multicenter prospective cohort study of endoscopic resection for early gastric cancer using Web registry
Acronym
J-WEB/EGC (Japanese Web registry study of EGC)
Scientific Title
Japanese multicenter prospective cohort study of endoscopic resection for early gastric cancer using Web registry
Scientific Title:Acronym
J-WEB/EGC (Japanese Web registry study of EGC)
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the current nationwide short-term and long-term results of endoscopic resection for early gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive patients with early gastric cancer who undergo endoscopic resection at the 41 Japanese institutions
from July 2010 to June 2012 are enrolled.
Key exclusion criteria
No written consentto this study
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Oda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
+81-3-3542-2511
ioda@ncc.go.jp
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Suzuki |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
+81-3-3542-2511
Homepage URL
harusuzu@ncc.go.jp
Sponsor or person
Institute
J-WEB/EGC group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
+81-3-3542-2511
Tel
+81-3-3542-2511
irst@ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006826
Publication of results
Published
Result
URL related to results and publications
doi: 10.1111/den.13246. doi: 10.1016/j.cgh.2022.07.029.
Number of participants that the trial has enrolled
9715
Results
Short-term outcomes (10,821 lesions). Median procedure time 76 min, R0 resections 91.6%, postoperative bleeding 4.4%, intraoperative perforation 2.3%. 2. Long-term outcomes (9054 patients). 5-year OS 89.0%. In a multivariate analysis, no significant differences were observed when the HR of Categories A2, A3 and B were compared to that of A1.
Results date posted
| 2022 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age, years (Range) 71.0 (28 96), Female/Male: 2206 (24.4%)/6848 (75.6%), PS0/PS1/PS2-4: 8339 (92.1%)/624 (6.9%)/91 (1.0%), Concomitant and past history; Malignant neoplasm/Cerebrovascular disease/Heart disease/Diabetes mellitus/Chronic kidney disease/Chronic hepatitis and/or liver cirrhosis: 1729 (19.1%)/543 (6.0%)/520 (5.7%)/1113 (12.3%)/175 (1.9%)/295 (3.3%), Naive stomach/Remnant stomach/Gastric tube: 8579 (94.8%)/369 (4.1%)/106 (1.2%), History of ER for other gastric cancer lesions 1189 (13.1%), ESD/EMR/other: 9014 (99.6%)/39 (0.4%)/1 (0%), Treatment history of the enrolled lesion (locally recurrent lesion) 134 (1.5%)
Participant flow
9715 patients with 10,926 lesions who consented to participate in this study were enrolled. ER procedures were completed in 9610 patients with 10,815 lesions. Based on the histopathological findings, 10,031 lesions in 9062 patients were identified as common-type gastric cancers. After excluding 8 patients with 10 lesions due to withdrawal of consent or duplicate registration during the collection of information on the long-term outcome, the long-term outcomes of 9054 patients with 10,021 lesions were analyzed.
Adverse events
postoperative bleeding 4.4%, intraoperative perforation 2.3%.
Outcome measures
Primary endpoint 5-year overall survival (OS). Hazard ratio (HR) for all-cause mortality was calculated using the Cox proportional hazards model. As for pathological curability, HR of Categories A2 (differentiated-type, pT1a, UL-, >2 cm or UL+, <=3 cm), A3 (undifferentiated-type, pT1a, UL-, <=2 cm), B (differentiated-type, pT1b (SM1), <=3 cm) and C (noncurative resection) were compared with that of Category A1 (differentiated-type, pT1a, UL-, <=2 cm).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006826
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/08/24 | Study protocol.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
