UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044679 |
|---|---|
| Receipt number | R000051009 |
| Scientific Title | Evaluation of a diagnostic algorithm of magnifying endoscopy with crystalviolet staining for duodenal epithelial tumors |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/12/30 16:06:19 |
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Basic information
Public title
Evaluation of a diagnostic algorithm of magnifying endoscopy with crystalviolet staining for duodenal epithelial tumors
Acronym
Evaluation of a diagnostic algorithm of ME-CV for duodenal epithelial tumors
Scientific Title
Evaluation of a diagnostic algorithm of magnifying endoscopy with crystalviolet staining for duodenal epithelial tumors
Scientific Title:Acronym
Evaluation of a diagnostic algorithm of ME-CV for duodenal epithelial tumors
Region
| Japan |
Condition
Condition
Duodenal epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of a diagnostic algorithm of ME-CV for duodenal epithelial tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and negative predictive value of theME-CV diagnostic algorithm
Key secondary outcomes
1. Comparison of the diagnostic performance between the white light endoscopy scoring system and the MECV diagnostic algorithm
2. Comparison of diagnostic performance between expert and non-expert groups
3. Comparison of the diagnostic Performance of the white light endoscopy scoring system and the MECV diagnostic algorithm according to mucin phenotype
4. Interobserver agreement between the white light endoscopy scoring system and the MECV diagnostic algorithm
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed with duodenal epithelial tumors
Patients over 20years old
Key exclusion criteria
Patients with residual recurrence after endoscopic treatment
Patients who are considered difficult to register by the doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3694
Address
Idaidori 1-1-1, Yahaba,Iwate, Japan
TEL
+81-19-651-5111
tmastumo@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Toya |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3694
Address
Idaidori 1-1-1, Yahaba, Iwate, Japan
TEL
+81-19-651-5111
Homepage URL
ytoya@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate 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
The ethical committee of Iwate Medical University
Address
Idaidori 1-1-1, Yahaba, Iwate, Japan
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
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
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of a diagnostic algorithm of ME-CV for duodenal epithelial tumors
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051009
