UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022928 |
|---|---|
| Receipt number | R000026414 |
| Scientific Title | Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection. |
| Date of disclosure of the study information | 2016/06/29 |
| Last modified on | 2016/06/28 15:19:00 |
* 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
Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Acronym
Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Scientific Title
Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Scientific Title:Acronym
Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Region
| Japan |
Condition
Condition
Surveillance of gastric cancer using endoscopy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to evaluate the usefulness of LCI for gastric cancer detection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of Gastric cancer by using LCI or white-light imaging (WLI).
Key secondary outcomes
Added efficacy of examination with LCI on the detection rate of gastric cancer in conventional WLI observation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic examination with LCI before conventional WLI observation.
Interventions/Control_2
Endoscopic examination with LCI after conventional WLI observation.
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 before undergoing an endoscopic or surgical resection of early gastric cancer or Patients with follow-up after endoscopic resection of gastric cancer.
2. Patients can perform endoscopic biopsy when necessary.
3. Patients with informed consent.
Key exclusion criteria
1. Patients with advanced Gastric cancer.
2. The history of surgical gastric resection.
3. Patients has determined that inappropriate by principal investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamaguchi |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Internal Medicine
Zip code
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-1111
ytatsuya@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamaguchi |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Internal Medicine
Zip code
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-9584
Homepage URL
ytatsuya@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
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
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
| 2016 | Year | 06 | Month | 29 | 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
Date of protocol fixation
| 2016 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 29 | 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
| 2016 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026414
