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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001608
Receipt No. R000001932
Scientific Title Establishment of surveillance system for the longstanding ulcerative colitis patients Comparative study of efficacy for the targeted biopsy and the step biopsy
Date of disclosure of the study information 2009/01/05
Last modified on 2015/07/28

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Basic information
Public title Establishment of surveillance system for the longstanding ulcerative colitis patients
Comparative study of efficacy for the targeted biopsy and the step biopsy
Acronym Establishment of surveillance system for the longstanding ulcerative colitis patients
Scientific Title Establishment of surveillance system for the longstanding ulcerative colitis patients
Comparative study of efficacy for the targeted biopsy and the step biopsy
Scientific Title:Acronym Establishment of surveillance system for the longstanding ulcerative colitis patients
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy between the targeted biopsy and the step biopsy by RCT (randomized controlled trial) in the surveillance colonoscopy to detect cancer and/ or dysplasia for the longstanding ulcerative colitis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of neoplastic lesions detected during surveillance colonoscopy
Key secondary outcomes The detection rate of neoplastic lesions, examination time and a number of biopsies in the surveillance colonoscopy (economical efficiency, incidence rate of complication that requires the special treatment, risk factor of neoplasia)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Targeted biopsy
Interventions/Control_2 Step biopsy
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 1)Patients who has a histologically confirmed diagnosis of ulcerative colitis (Duration of disease 7 years or more, total colitis or left-sided colitis)

2)Simple clinical colitis activity index <= 8

3)Activity Index of Truelove and Witts: mild

4)Patients who can understand the concept of the study and consented to participate in the study

Key exclusion criteria 1)Patients who have past history of colon cancer and/or ulcerative colitis associated neoplasm

2) Patients suspected of bleeding diathesis or coagulation abnormality

3) Renal dysfunction (Cre > 1.2 mg/dl)

4)Pregnancy or breast feeding

5)Otherwise, patiesnts who investigator judged ineligible to register

Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Watanabe, M.D., Ph.D.
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga Itabashiku Tokyo
TEL 03-3964-1231
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Tomotsugu
Organization Keio University School of Medicine
Division name Center for Clinical Research
Zip code
Address 35 Shinanomachi Shinjuku Tokyo
TEL 03-5363-3288
Homepage URL
Email naokit@sc.itc.keio.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Research Committee of IBD by The Ministry of Health and Welfare, JSCCR (Japanese society for cancer of the colon and rectum)
Organization
Division
Category of Funding 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
2009 Year 01 Month 05 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
2008 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 29 Day
Last modified on
2015 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001932

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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