UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019438
Receipt No. R000022482
Scientific Title Diagnosis of intestinal metaplasia in gastric mucosa using Linked Color Imaging(LCI)
Date of disclosure of the study information 2015/10/21
Last modified on 2015/10/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Diagnosis of intestinal metaplasia in gastric mucosa using Linked Color Imaging(LCI)
Acronym Japan LCI intestinal metaplasia Study
Scientific Title Diagnosis of intestinal metaplasia in gastric mucosa using Linked Color Imaging(LCI)
Scientific Title:Acronym Japan LCI intestinal metaplasia Study
Region
Japan

Condition
Condition Stomach tumor-related lesion
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify the usefulness of LCI images to diagnose intestinal metaplasia in the background mucosa during the detailed examination of gastric tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastric biopsied specimens will be taken from the purple change mucosa suspicious of intestinal metaplasia by LCI images, compared with BLI images. Similarly, specimens will be taken from brown change mucosa suspicious of non-intestinal metaplasia. Based on the pathological findigs, sensitivity, specificity and accuracy will be evaluated.
Key secondary outcomes Based on histological assessment of endoscopically resected specimens, the usefulness of LCI will be evaluated about the extent of tumor by color contrast between the tumor and the surrounding mucosa. .In addition, the color difference will be measuerd using a color space International Lighting Commission recommended in 1976 in order to quantify such color contast and assess visibility of tumors by LCI.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Pathological diagnosis with endoscopy
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) More than 20 years old
2) Patient with gastric tumor acompanied by chronic gastric inflammatory mucosa.
Key exclusion criteria 1) Acute abdomen
2) Severe inflammation
3)Poor general condition patients who has risk for performing endoscopy such as ileus, perforation of intestine, pancreatitis respiratory disorder, heart failure, acquired hemophilia, intestinal stricture and large ulcer or tumor of digestve tract.
3) Patients who take peroral multiple drugs including anti-platelets and anti-coagulants, leading to difficulty to take a biopsy.
5) Patients who experienced entry of this study.
6) Patient who is judged to be unsuitable for this clinical trial.
7) Patients who are difficult to be sublect the informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Osawa,M.D.,Ph.D
Organization Jichi Medical University
Division name Department of Internal Medicine
Zip code
Address 3311-1 Yakushiji,Shimomituke,Tochigi,JAPAN 329-0498
TEL 0285-58-7539
Email osawa@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Fukuda,M.D
Organization Jichi Medical University
Division name Department of Internal Medicine
Zip code
Address 3311-1 Yakushiji,Shimomituke,Tochigi,JAPAN 329-0498
TEL 0285-58-7539
Homepage URL
Email r0849hf@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization FUJIILM MEDICAL Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 10 Month 21 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 21 Day
Last modified on
2015 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.