UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025275
Receipt number R000028981
Scientific Title Study of the new type image-enhanced endoscopy with LED in the diagnosis of gastric tumors
Date of disclosure of the study information 2017/01/04
Last modified on 2019/06/21 16:07:25

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Basic information

Public title

Study of the new type image-enhanced endoscopy with LED in the diagnosis of gastric tumors

Acronym

Diagnosis of gastric tumors with the new type image-enhanced endoscopy with LED

Scientific Title

Study of the new type image-enhanced endoscopy with LED in the diagnosis of gastric tumors

Scientific Title:Acronym

Diagnosis of gastric tumors with the new type image-enhanced endoscopy with LED

Region

Japan


Condition

Condition

Gastric tumor

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare ability of the new type image-enhanced endoscopy with LED and current type about diagnosis of gastric tumors

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concordance rate of diagnostic ability of gastric tumors between the new type image-enhanced endoscopy with LED and current type

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Adult patients of gastric tumors who gave written informed consent

Key exclusion criteria

The patients that an agreement is not obtained
The patients that doctor attending judged an arrangement to this study to be inadequate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto prefectural university of medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5111

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Dohi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5111

Homepage URL


Email

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


Sponsor or person

Institute

Kyoto prefectural university of medicine department of gastroenterology and hepatology

Institute

Department

Personal name



Funding Source

Organization

Kyoto prefectural university of medicine department of gastroenterology and hepaology

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

Kyoto Prefectural University of Medicine

Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

Tel

075-251-5111

Email

shunt02@koto.kpu-m.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

京都府立医科大学付属病院


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 04 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

Enrolling by invitation

Date of protocol fixation

2016 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We compare ability of the new type image-enhanced endoscopy with LED and current type about diagnosis of gastric tumors


Management information

Registered date

2016 Year 12 Month 14 Day

Last modified on

2019 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name