UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022204 |
|---|---|
| Receipt number | R000024916 |
| Scientific Title | Detection of early gastric cancer using image-enhanced endoscopy |
| Date of disclosure of the study information | 2016/05/04 |
| Last modified on | 2021/06/25 16:32:18 |
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Basic information
Public title
Detection of early gastric cancer using image-enhanced endoscopy
Acronym
Detection of early gastric cancer using image-enhanced endoscopy
Scientific Title
Detection of early gastric cancer using image-enhanced endoscopy
Scientific Title:Acronym
Detection of early gastric cancer using image-enhanced endoscopy
Region
| Japan |
Condition
Condition
atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate detection of early gastric cancer usig image-enhanced endoscopy for patients with atrophic gastritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection rate of early gastric cancer
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who undergo EGD with atrophic gastritis
Key exclusion criteria
post gastrectomy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
imaedahi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
imaedahi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-2107
hirb@saitama-med.ac.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
| 2016 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000024916
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000024916
Number of participants that the trial has enrolled
577
Results
16 gastric neoplasms (3.2%) were detected. 11 EGCs and one gastric adenoma (75%) were detected by first WLI mode, whereas 4 EGCs (25%) were missed by the first WLI mode and were detected by LCI mode or BLI-bright mode. All of them were less than 1cm in diameter, reddish, one was protruded type and 3 were depressed type. Mean diameter of the lesions was 7.8mm and significantly less than that (21.2mm) of the lesions detected by the first WLI mode.
Results date posted
| 2019 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
atrophic gastritis
Participant flow
patients undergoing screening EGD
Adverse events
none
Outcome measures
The size, morphology and color of 1 gastric neoplasms detected by first WLI mode and those detected not by WLI mode but by LCI mode or BLI-bright mode were compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
First, conventional endoscopy
Second, BLI mode and LCI mode
Third, endoscopy using indigocarmine dye spraying
Finally, pathological diagnosis by biopsy specimen
Management information
Registered date
| 2016 | Year | 05 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024916
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/05/12 | 臨床研究実施計画書LCI.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
