UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005074 |
|---|---|
| Receipt number | R000006038 |
| Scientific Title | Evaluation of endoscopic mucosal activity, non-relapsing rates and detection rates of both colonic cancer and dysplasia by using FICE (flexible spectral imaging color enhancement) system for patients with ulcerative colitis |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2018/01/02 21:25:27 |
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Basic information
Public title
Evaluation of endoscopic mucosal activity, non-relapsing rates and detection rates of both colonic cancer and dysplasia by using FICE (flexible spectral imaging color enhancement) system for patients with ulcerative colitis
Acronym
Evaluation of endoscopic mucosal activity, non-relapsing rates and detection rates of both colonic cancer and dysplasia by using FICE system for patients with ulcerative colitis
Scientific Title
Evaluation of endoscopic mucosal activity, non-relapsing rates and detection rates of both colonic cancer and dysplasia by using FICE (flexible spectral imaging color enhancement) system for patients with ulcerative colitis
Scientific Title:Acronym
Evaluation of endoscopic mucosal activity, non-relapsing rates and detection rates of both colonic cancer and dysplasia by using FICE system for patients with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation of endoscopic mucosal activity and non-relapsing rates, and detection rates of both colonic cancer and dysplasia by using FICE
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vascular grading
non-relapsing rates
detection rates of both colonic cancer and dysplasia
Key secondary outcomes
Clinical activity index
White blood cell count, Platelet count, Erythrocyte sedimentation rates, CRP
Pathological Matts grading
Endoscopic ultrasonographic evaluation
Concordance of FICE appearance and pathological specimens
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnifing Endoscopic Examination with FICE system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who can receive colonoscopic examination
Patients who receive informed consents
Key exclusion criteria
Patients who cannot receive colonoscopic examination because of their poor clinical condition and bad diagnostic imaging
Patients who refuse informed consents
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama medical University
Division name
Department og gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama medical University
Division name
Department og gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama medical 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
| 2011 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006038
