UMIN-CTR Clinical Trial

Public title

multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

Acronym

multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

Scientific Title

multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

Scientific Title:Acronym

multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

Region

Japan

Condition

gastric low-grade intraepithelial neoplasia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the proportion of cancer diagnosed after Endoscopic Resection (ER) among patients with gastric low-grade intraepithelial neoplasia.

Basic objectives2

Others

Basic objectives -Others

observational study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The proportion of patients diagnosed as cancer after ER by central review among patients with category 3 of Vienna classification diagnosed by endoscopic forceps biopsy specimen by central review.

Key secondary outcomes

1) The proportion of patients diagnosed as cancer after ER by central review of histology among all included patients.
2) The short-term outcomes of ER.
Rate of adverse event (based on NCI-CTCAE ver. 4.0)
En bloc margin negative rate of ESD
Procedure duration
3) Histological findings of resected specimen.
histological type
presence or absence of vessels involvement
horizontal and vertical margin
4) Endoscopic findings.
macroscopic type (based on Paris classification)
the size of lesion
color
surface pattern
the findings of NBI Magnified Endoscopy

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) To be diagnosed as category 3 of Vienna classification (equivalent to Group 3 (and Group 4) of Japanese Classification of Gastric Carcinoma
March 2010 (The 14th Edition)) pathologically by endoscopic forceps specimen.
2) Not to be accompanied with ulcer.
3) age >= 20 years old.
4) Written informed consent has been obtained.

Key exclusion criteria

1) To have bleeding tendency.
2) Unable to interrupt anticoaglant for ER.
3) To be judged inapropriate to participate this trial by contact person.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuo Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871 Japan

TEL

06-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tsutomu Nishida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871 Japan

TEL

06-6879-3621

Homepage URL

Email

tnishida@gh.med.osaka-u.ac.jp

Institute

Osaka University ESD Study Group

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

03

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

03

Month

11

Day

Date of IRB

2012

Year

02

Month

16

Day

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

2014

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design: multi-center prospective study
Target sample size: 100
Method:
Patients who meets inclusion criteria undergoes ER.
The histological findings are evaluated according to Vienna classification for forceps biopsy specimen and according to WHO classification for ER specimen. In this study, central review of histology is performed by blinding the clinical informations.

Registered date

2012

Year

03

Month

09

Day

Last modified on

2023

Year

04

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008770