UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040698 |
|---|---|
| Receipt number | R000046456 |
| Scientific Title | Diagnostic ulcerative colitis assosiated neoplasia with endocytoscopy |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/06/09 14:57:38 |
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Basic information
Public title
Diagnostic ulcerative colitis assosiated neoplasia with endocytoscopy
Acronym
EC-UCAN
Scientific Title
Diagnostic ulcerative colitis assosiated neoplasia with endocytoscopy
Scientific Title:Acronym
EC-UCAN
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study was to demonstrate the diagnostic ability of combined EC irregularly-formed nuclei with PIT (EC-IN-PIT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated and compared the diagnostic abilities of PIT alone and EC-IN-PIT.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with UC whose lesions were observed by EC at the Showa University Northern Yokohama Hospital between February 2007 and April 2020.
Key exclusion criteria
Exclusion criteria were lesions histologically diagnosed as sporadic neoplasia, nondifferentiable lesions between UCAN and sporadic neoplasia, and nondifferentiable lesions between neoplasia and non-neoplasia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shin-ei |
| Middle name | |
| Last name | Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tuduki-ku Yokohama
TEL
0459497000
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | Wakamura |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tuduki-ku Yokohama
TEL
0459497000
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital IRB
Address
35-1 Chigasakichuo Tuduki-ku
Tel
+81459497000
irb02syh@ofc.showa-u.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
| 2020 | Year | 06 | Month | 12 | 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
103
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
| 2020 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
First Strategy: PIT alone diagnosis.
Second Strategy: EC-IN-PIT (combined EC irregular nuclei with PIT) diagnosis:
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046456
