UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003120 |
|---|---|
| Receipt number | R000003785 |
| Scientific Title | Diagnosis of metachronous recurrence after endoscopic submucosal dissection for gastric neoplasia using autofluorescence imaging |
| Date of disclosure of the study information | 2010/01/31 |
| Last modified on | 2011/07/31 11:10:48 |
* 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 metachronous recurrence after endoscopic submucosal dissection for gastric neoplasia using autofluorescence imaging
Acronym
Diagnosis of metachronous recurrence after ESD for gastric neoplasia using AFI
Scientific Title
Diagnosis of metachronous recurrence after endoscopic submucosal dissection for gastric neoplasia using autofluorescence imaging
Scientific Title:Acronym
Diagnosis of metachronous recurrence after ESD for gastric neoplasia using AFI
Region
| Japan |
Condition
Condition
early gastric cancer or gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Some lesions can't be detected by white light endoscopy(WLE) beause of small lesisons or difficult location. The aim of this study is to compare detection rate of WLE with that of WLE and AFI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection rate of metachronous lesions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
WLE
Interventions/Control_2
WLE and AFI
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
patients after ESD for early gastric cancer or gatric adenoma
Key exclusion criteria
after gastrectomy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Imaeda |
Organization
School of Medicine, Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan, 160-8582
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
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
| 2010 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 31 | Day |
Last modified on
| 2011 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003785
