UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033390 |
|---|---|
| Receipt number | R000038070 |
| Scientific Title | Prospective comparative study of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication |
| Date of disclosure of the study information | 2018/07/14 |
| Last modified on | 2020/05/12 18:27:55 |
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Basic information
Public title
Prospective comparative study of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Acronym
Image enhanced endoscopy in early gastric cancer after H. pylori eradication
Scientific Title
Prospective comparative study of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Scientific Title:Acronym
Image enhanced endoscopy in early gastric cancer after H. pylori eradication
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective evaluation of diagnostic utility of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic specificity of gastric cancer in real time endoscopic diagnosis
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Generation Safety
Key exclusion criteria
1. Those who cannot undergo endoscopic biopsy (hematopoietic diseases etc.)
2. Those who cannot stop antiplatelet or anticoagulant under the guideline of Japan Gastroenterological Endoscopy Society.
3. Those who have severe allergy.
4. Those who have severe lung, kidney and heart diseases.
5. Those who have severe infection.
6. Those who cannot undergo adequate endoscopic examination.
7. Those who the physician considered them no to be suitable to enroll the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomitsu Tahara |
Organization
Fujita Health University
Division name
Gastroenterology
Zip code
Address
1-98 dengakugakubo kutsukakecyo toyoake
TEL
0562-93-9240
shokakan@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomitsu Tahara |
Organization
Fujita Health University
Division name
Gastroenterology
Zip code
Address
1-98 dengakugakubo kutsukakecyo toyoake
TEL
0562-93-9240
Homepage URL
ttahara@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
HM18-134
Org. issuing International ID_1
HM18-134
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 07 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038070
