UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009667 |
|---|---|
| Receipt number | R000011340 |
| Scientific Title | prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV) |
| Date of disclosure of the study information | 2012/12/30 |
| Last modified on | 2015/09/01 21:13:26 |
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Basic information
Public title
prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV)
Acronym
The reactivation of cytogegalovirus in patients with ulcerative colitis
Scientific Title
prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV)
Scientific Title:Acronym
The reactivation of cytogegalovirus in 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
prospective cohort study of the prognosis in UC patients with reactivation of cytomeglovurus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate in UC patients who are treataed and untreated with gancycrovir at 2 weeks after regstration of the study.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Definitive UC patients
2 Disease Activity Index is 6-12 points
3 Either inpatients or outerpatients
4 equal or more than 16 yeras-old
Key exclusion criteria
1 patients have been entried to other clinical trial or clinical study
2 patients are planned to surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Suzuki |
Organization
Toho University, Medical Center, Sakura Hospital
Division name
Gastroenterology
Zip code
Address
564-1, Shimoshizu, Sakura City, Chiba prefecture
TEL
81-43-462-8811
ibd.gast@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
Keio University, School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-KU Tokyo
TEL
81-3-3353-1211
Homepage URL
cmvproject.meeting@gmail.com
Sponsor or person
Institute
Toho University, Medical Center, Sakura Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan.
Organization
Division
Category of Funding 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
| 2012 | Year | 12 | Month | 30 | 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
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study has been proceeded
Management information
Registered date
| 2012 | Year | 12 | Month | 30 | Day |
Last modified on
| 2015 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011340
