UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009808
Receipt number R000011496
Scientific Title Prospective study of usefulness of magnifying Narrow band imaging for Sessile serrated adenoma/polyp
Date of disclosure of the study information 2013/01/21
Last modified on 2015/01/25 21:30:01

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Basic information

Public title

Prospective study of usefulness of magnifying Narrow band imaging for Sessile serrated adenoma/polyp

Acronym

Prospective study of usefulness of magnifying NBI for SSA/P

Scientific Title

Prospective study of usefulness of magnifying Narrow band imaging for Sessile serrated adenoma/polyp

Scientific Title:Acronym

Prospective study of usefulness of magnifying NBI for SSA/P

Region

Japan


Condition

Condition

Sessile serrated adenoma/polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the usefulness of mangnifying Narrow band imaging in the differential diagnosis of Hyperplastic polyp and Sessile serrated adenoma/polyp

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnosis ability of magnifying Narrow band imaging for Sessile serrated adenoma/polyp

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Magnifying Narrow band imaging examination for Sessile serrated adenoma/polyp

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

Colorectal polyps

Key exclusion criteria

1) after right hemicolectomy
2) inflammatory bowel disease
3) patients whom a researcher judged to be inappropriate as a subject

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoji Takeuchi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address

3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Yamashina

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Gastrointestinal Oncology

Zip code


Address


TEL


Homepage URL


Email

yamasina-ta@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



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


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

2013 Year 01 Month 21 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

Completed

Date of protocol fixation

2013 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 19 Day

Last modified on

2015 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name