UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005962 |
|---|---|
| Receipt number | R000007047 |
| Scientific Title | Gastric cancer screening Labeled by serum examination in Place of Aged Gastric cancer Organized Screening System |
| Date of disclosure of the study information | 2011/07/14 |
| Last modified on | 2024/07/23 18:34:53 |
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Basic information
Public title
Gastric cancer screening Labeled by serum examination in Place of Aged Gastric cancer Organized Screening System
Acronym
Gastric cancer screening Labeled by serum examination in Place of Aged Gastric cancer Organized Screening System (GALAPAGOSS Study)
Scientific Title
Gastric cancer screening Labeled by serum examination in Place of Aged Gastric cancer Organized Screening System
Scientific Title:Acronym
Gastric cancer screening Labeled by serum examination in Place of Aged Gastric cancer Organized Screening System (GALAPAGOSS Study)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The destination of this randomized study is to compare the organized screening by Barium X-ray and new recommended screening system used by serum examination with Helicobacter pylori antibody and serum pepsinogen status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Comparison of mean medical fee per one examination
Key secondary outcomes
#Detection rate at the registration
#Detection rate and tumor stages at the final examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Barium X-ray
Interventions/Control_2
Serum examination and endoscopy
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
| 30 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
#Subject for the organized screening for gastric cancer resided in Honjyo-Yuri area, Akita prefecture
#Acceptance for enrollment and registration for this randomized study
Key exclusion criteria
#Subjects with gastric cancer
#Subjects with malignant disease with the past 5 years
#Subjects with history of surgery for gastro-duodenal ulcer
#Subjects with severe complications #Subjects with difficult agreement of enrollment and registration for this randomized study
#Ineligible subjects certified by doctors
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | GOTODA |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
takujigotoda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | GOTODA |
Organization
Nihon University Hospital
Division name
Division of Gastroenterology
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL
03-3293-1711
Homepage URL
takujigotoda@yahoo.co.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Research course for cancer prevention, screening and treatment of digestive tract, Department of Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6 Surugadai Kanda Chiyoda-ku, Tokyo Jaoan
Tel
03-3293-1711
takujigotoda@yahoo.co.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
地域がん診療連携拠点病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10120-023-01449-3
Number of participants that the trial has enrolled
1207
Results
The expenses required to detect one gastric cancer were 2,240,931 yen in Ba-Endo and 3,486,662 yen in ABC-Endo.
Results date posted
| 2024 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Using the minimisation method with sex and age as allocation factors, 1,206 participants were randomly assigned to the following two methods for a 5-year intervention: barium photofluorography as primary examination followed by detailed examination with upper gastrointestinal endoscopy (Ba-Endo) and risk-based upper gastrointestinal endoscopy by ABC classification (ABC-Endo).
Participant flow
In this open label study, participants were assigned to two groups, the existing system Ba-Endo group and the new system ABC-Endo group, using the minimisation method, with sex and age (30-59 years and 60-74 years) as allocation factors.
Adverse events
No adverse events are found.
Outcome measures
The primary endpoint was the total testing cost per participant over a 5-year period. The secondary endpoint was the expense required to detect one gastric cancer.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 11 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007047
