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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038535
Receipt No. R000043910
Scientific Title Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Date of disclosure of the study information 2019/11/12
Last modified on 2019/11/11

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Basic information
Public title Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Acronym Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Scientific Title Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Scientific Title:Acronym Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Region
Japan

Condition
Condition colitis-associated colorectal dysplasia (UCAD)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic ability of Endocytoscopy in ulcerative colitis-associated tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Qualitative diagnostic ability of ulcerative colitis-associated tumor
Key secondary outcomes Compare the diagnosis of the disease range of ulcerative colitis-associated tumor with pathological results

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 with consent by document
# Patients who are over 20 years old when the patients consent
# Patients with previously confirmed histopathological diagnosis of ulcerative colitis-associated tumor
# Patients with suspected ulcerative colitis-associated tumor
Key exclusion criteria # Patients who are judged as inappropriate by investigator
# Patients without the self judgement abilities

Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Yamamura
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 466-8550
Address 65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-741-2172
Email tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Issei
Middle name
Last name Hasegawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 466-8550
Address 65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-741-2172
Homepage URL
Email issei@med.nagoya-u.ac.jp

Sponsor
Institute Department of Endoscopy, Nagoya University Hospital
Institute
Department

Funding Source
Organization None
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 Nagoya University Hospital Ethics Review Committee
Address 65, Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel 052-741-2172
Email tyamamu@med.nagoya-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
2019 Year 11 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
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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
2018 Year 12 Month 14 Day
Anticipated trial start date
2019 Year 11 Month 12 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This observational study examines the diagnostic ability of Endocytoscopy in ulcerative colitis-associated colorectal dysplasia(UCAD)

Management information
Registered date
2019 Year 11 Month 11 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043910

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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