UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027354 |
|---|---|
| Receipt number | R000031345 |
| Scientific Title | Evaluation of gastric cancer risk using endoscopy |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2023/06/14 11:58:50 |
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Basic information
Public title
Evaluation of gastric cancer risk using endoscopy
Acronym
Evaluation of gastric cancer risk using endoscopy
Scientific Title
Evaluation of gastric cancer risk using endoscopy
Scientific Title:Acronym
Evaluation of gastric cancer risk using endoscopy
Region
| Japan |
Condition
Condition
gastric cancer, gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of gastric cancer risk by endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk grade of atrophy and intestinal metaplasia in white light imaging
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 hope to check H. pylori status
Patinets who receive further examinatuon of gastric cancer
Key exclusion criteria
Patinets who can not receive biopsy
Patinets who received gastrectomy
Patinets who had history of gastric cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
0608648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
0608648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
Homepage URL
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Divison of Endoscopy, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self fundong
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
Hokkaido University Hospital IRB
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
Tel
0117161161
crjimu@huhp.hokudai.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
| 2017 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
199
Results
Data for 84 patients in the gastric cancer group and 89 patients in the non-gastric cancer group were analyzed. The AUC values forO-2 and O-3 and IM of corpus were 0.70, respectively.
Results date posted
| 2021 | Year | 05 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive outpatients undergoing esophagogastroduodenoscopy for screening and workup of early gastric cancer
Participant flow
Patients were enrolled before EGD.　Exclusion criteria were age less than 50 years, use of an antacid, previous gastric neoplasia or surgery, and contraindication for biopsy.
Adverse events
none
Outcome measures
endoscopic atrophy and intestinal metaplasia
histologic atrophy and intestinal metaplasia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1Characteristics of Patients
2Blood tests
3Urea breath test
4GSRS
5Endoscopic imges
6Biopsy samples
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031345
| Research Plan | |
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| Registered date | File name |
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