UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001608 |
|---|---|
| Receipt number | 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 15:52:35 |
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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
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
naokit@sc.itc.keio.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001932
