UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022246 |
|---|---|
| Receipt number | R000023712 |
| Scientific Title | Development of Patients Reported Outcome of Ulcerative Colitis:prospective multicenter cohort study |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2016/05/16 16:11:07 |
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Basic information
Public title
Development of Patients Reported Outcome of Ulcerative Colitis:prospective multicenter cohort study
Acronym
PROUC study
Scientific Title
Development of Patients Reported Outcome of Ulcerative Colitis:prospective multicenter cohort study
Scientific Title:Acronym
PROUC study
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of patients reported outcome
of ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission after 14 weeks from the start of anti TNF alpha
Key secondary outcomes
Lichtiger score <=4(6 week), Lichtiger score<=2(6,14 week), clinicak effecacy rate(6,14 week),DAI score(14 week), partial DAI score(6,14 week), negative CRP rate(6,14 week),CRP(6,14 week), EQ-5D-3L(1,2,4,8,12 week) QALY, endoscopic remission(12 week)
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
moderate and severe UC
Key exclusion criteria
Past history of anti TNF alpha treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-3-5363-3790
maknaganuma@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayasu Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-3-5363-3790
Homepage URL
masayasu-horibe@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 05 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design:prospective multicenter cohort study.
Objective:All consective patients who meet selective citeria in each insntitution.
Length: 2016 April to 2018 March
Primary outcome:Clinical remission at 14 weeks after treatment
Secondary outcome:Lichtiger score, DAI score, partial DAI score, CRP, EQ-5D-3L, QALY, endoscopic remission
Management information
Registered date
| 2016 | Year | 05 | Month | 09 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023712
