UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012348
Receipt number R000014384
Scientific Title Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms
Date of disclosure of the study information 2014/02/01
Last modified on 2016/12/11 17:29:32

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Basic information

Public title

Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms

Acronym

Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms

Scientific Title

Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms

Scientific Title:Acronym

Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms

Region

Japan


Condition

Condition

colorectal neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Usefulness of IEE for colorectal neoplasms

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Usefulness of IEE for colorectal neoplasms

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1,Patients that Endoscopic biopsy or resection or surgical resection of colorectal neoplasms is planned
2,20 years old or older
3,Patients who provided written informed consent

Key exclusion criteria

1,Patients who judged that we are inappropriate
2,Patients without the ability for self-decision
3,Colorectal neoplasms with chemotherapy or radiation therapy

Target sample size

210


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanao Nakamura

Organization

Nagoya University Hospital

Division name

Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2172

Email

makamura@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Arihiro Nakano

Organization

Nagoya University Hospital

Division name

Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2172

Homepage URL


Email

arihiro-31@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Hepatology, Nagoya University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 02 Month 01 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

Open public recruiting

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 27 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Comparison of IEE(BLI or NBI) versus white lignt and chromoendoscopy for detection rate and diagnosis of colorectal neoplasms


Management information

Registered date

2013 Year 11 Month 19 Day

Last modified on

2016 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014384


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name