UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010115 |
|---|---|
| Receipt number | R000011854 |
| Scientific Title | The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2014/08/25 20:49:25 |
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Basic information
Public title
The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis
Acronym
Association of I-FOBT with UCCIS in quiescent ulcerative colitis patients
Scientific Title
The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis
Scientific Title:Acronym
Association of I-FOBT with UCCIS in quiescent ulcerative colitis patients
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of I-FOBT with UCCIS in quiescent ulcerative colitis patients and to evaluate the utility of I-FOBT to predict relapse as a noninvasive screening examination
Basic objectives2
Others
Basic objectives -Others
The investigation of the efficacy of I-FOBT for the natural course of ulcerative colitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between I-FOBT and UCCIS
Key secondary outcomes
relapse rate and time to relapse
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients
2) Adult patients who have been diagnosed as ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on January 26, 2012)
3) Those who are diagnosed in the clinically remission stage (PGA=0)
4) Patients who were induced remission with SASP, mesalazine, steroid or immunomodulator and are maintained with those drugs
5) Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study
Key exclusion criteria
1) Patients who have received total / subtotal colectomy
2) Patients who have been complicated or have history with malignant tumor
3) Patients who were induced or maintained remission with biologics
4) Patients who needed dose-increase or addition of drug for maintenance of remission during study period
5) Patients who are pregnant or possibly pregnant
6) Other patients whom investigators and subinvestigators considered inappropriate to participate in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 02 | Month | 28 | 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
| 2013 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
To investigate the relationship between I-FOBT and endoscopic findings of the patients with ulcerative colitis in remission phase prospectively. The medication will be changed to 2g/day of 5-ASA.
Management information
Registered date
| 2013 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011854
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
