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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005074
Receipt No. 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

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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
Email 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
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006038

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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