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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007476
Receipt No. R000008770
Scientific Title multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia
Date of disclosure of the study information 2012/03/12
Last modified on 2014/04/03

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Basic information
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
Condition gastric low-grade intraepithelial neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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) 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

Research contact person
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

Public contact
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

Sponsor
Institute Osaka University ESD Study Group
Institute
Department

Funding Source
Organization none
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 03 Month 12 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 No longer recruiting
Date of protocol fixation
2012 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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.

Management information
Registered date
2012 Year 03 Month 09 Day
Last modified on
2014 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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