UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007641
Receipt number R000008961
Scientific Title Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers
Date of disclosure of the study information 2012/04/02
Last modified on 2015/10/05 15:52:31

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Basic information

Public title

Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers

Acronym

Diagnosis of demarcation of early gastric cancers

Scientific Title

Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers

Scientific Title:Acronym

Diagnosis of demarcation of early gastric cancers

Region

Japan


Condition

Condition

early garic cancer

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare diagnostic ability of magnifying endoscopy with narrow band imaging and chromoendoscopy with indigocarmine about demarcation of early gastric cancers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of accurate diagnosis of demarcation of early gastric cancers

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

marking dots for demarcation of tumors

Interventions/Control_2

marking dots for demarcation of tumors

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 early gastric cancer who will undergo endoscopic submucosal dissection at our hospital and gave written informed consent

Key exclusion criteria

patients of type 0-I cancer
patients whose cancers locate at the
greater curvature of gastric body
patients of residual cancers after
endoscopic resection
patients whose cancer was resected in
a piecemeal fashion
patients of gastric tube or post-
gastrectomy
cancers whose diameter is less than 10 mm

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Kodashima

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

kodashima-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Itsuko Asada-Hirayama

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

ihirayama-tky@umin.ac.jp


Sponsor or person

Institute

the Department of Gastroenterology, Graduate School
of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Laboratory 108, the Department of Gastroenterology

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

2012 Year 04 Month 02 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

2011 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 01 Day

Date analysis concluded

2015 Year 01 Month 10 Day


Other

Other related information



Management information

Registered date

2012 Year 04 Month 02 Day

Last modified on

2015 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name