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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name