UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009216
Receipt number R000010824
Scientific Title The utility of new endoscopic system using the laser source for the diagnosis of gastric cancer
Date of disclosure of the study information 2012/11/01
Last modified on 2018/05/13 13:17:46

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Basic information

Public title

The utility of new endoscopic system using the laser source for the diagnosis of gastric cancer

Acronym

The utility of new endoscopic system using the laser source for the diagnosis of gastric cancer

Scientific Title

The utility of new endoscopic system using the laser source for the diagnosis of gastric cancer

Scientific Title:Acronym

The utility of new endoscopic system using the laser source for the diagnosis of gastric cancer

Region

Japan


Condition

Condition

early gastric cancer and suspicious of early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the usefulness of new endoscopic system using the laser source for the diagnosis of early gastric cancer and suspicious of early gastric cancer magnified images

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnosis ability of magnified endoscopic images by new endoscopic system according to VS classification

Key secondary outcomes

Degree of diagnosis agreement according to VS classification of magnified endoscopic images with new endoscopic system and narrow band imaging


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

endoscopic examination using new system

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with suspicious of early gastric cancer

Key exclusion criteria

Patients whom a researcher judged to be inappropriate as a subject

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Dohi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

osamu-d@koto.kpu-m.ac.jp


Sponsor or person

Institute

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

京都府立医科大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2012 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete

2015 Year 09 Month 30 Day

Date analysis concluded

2015 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 29 Day

Last modified on

2018 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010824


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/05/12 M-BLI Gastric Cancer dohi.pdf