UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035637
Receipt number R000040409
Scientific Title Accuracy of pathological diagnosis of frozen section in gastric ESD
Date of disclosure of the study information 2019/01/28
Last modified on 2019/01/23 13:28:50

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Basic information

Public title

Accuracy of pathological diagnosis of frozen section in gastric ESD

Acronym

Accuracy of pathological diagnosis of frozen section in gastric ESD

Scientific Title

Accuracy of pathological diagnosis of frozen section in gastric ESD

Scientific Title:Acronym

Accuracy of pathological diagnosis of frozen section in gastric ESD

Region

Japan


Condition

Condition

Early gastric cancer or gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate accuracy of pathological diagnosis of frozen section as a fundamental study on rapid biopsy during gastric ESD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy of pathological diagnosis of frozen section in resected specimen of gastric ESD(positive predictive value, negative predictive value, sensitivity, specificity)

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 who can consent in writing for participation in this study
2. Patients who receive treatment with ESD and whose pathological specimens can be created

Key exclusion criteria

1. Patients who are interrupted treatment with ESD for some reason
2. Patients who are judged inappropriate for this study by the doctor

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoki Inaba

Organization

Kagawa Prefectural Central Hospital

Division name

Gastroenterology

Zip code


Address

1-2-1 Asahi-machi, Takamatsu-city, Kagawa, Japan

TEL

087-811-3333

Email

t-inaba@chp-kagawa.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigenao Ishikawa

Organization

Kagawa Prefectural Central Hospital

Division name

Gastroenterology

Zip code


Address

1-2-1 Asahi-machi, Takamatsu-city, Kagawa, Japan

TEL

087-811-3333

Homepage URL


Email

ishikawa5308@yahoo.co.jp


Sponsor or person

Institute

Kagawa Prefectural Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Kagawa Prefectural Central Hospital

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



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 28 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

Preinitiation

Date of protocol fixation

2019 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Not applicable


Management information

Registered date

2019 Year 01 Month 23 Day

Last modified on

2019 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name