UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033740 |
|---|---|
| Receipt number | R000038476 |
| Scientific Title | Influence of the cytapheresis on cytomegalovirus reactivation complicated with ulcerative colitis: a prospective study |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2021/06/06 11:58:29 |
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Basic information
Public title
Influence of the cytapheresis on cytomegalovirus reactivation complicated with ulcerative colitis: a prospective study
Acronym
Cytapheresis for CMV reactivation in UC
Scientific Title
Influence of the cytapheresis on cytomegalovirus reactivation complicated with ulcerative colitis: a prospective study
Scientific Title:Acronym
Cytapheresis for CMV reactivation in UC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess value of cytapheresis for cytomegalovirus reactivation in patients with ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intent of the study is to assess changes of the number of anti-cytomegalovirus pp65 positive cells in the patients with ulcerative colitis before and after the column and single CAP.
Key secondary outcomes
1. To assess changes of the number of anti-cytomegalovirus pp65 positive cells in the patients with ulcerative colitis before and after the column and single CAP.
2. Serologic marker
3. Endoscopic activity
4. Clinical severity index
5. Histological findings: histological activity; Immunohistostaining; The presence of nuclear inclusions
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients fulfilling all of the following criteria were subjected to the survey.
1. Diagnosed UC patients who underwent CAP according to well-known criteria.
2. Patients who understood the purpose of experiment and signed a consent form.
3. Patients with CMV reactivation.
Key exclusion criteria
1. The patient allergic to anticoagulant drugs.
2. When the principal investigator considered not suitable.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
03-3444-6161
sagami@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
0334446161
Homepage URL
jaken1013@live.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
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
Kitasato University Kitasato Institute Hospital
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
03-3444-6161
sagami@insti.kitasato-u.ac.jp
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
| 2018 | Year | 09 | Month | 18 | 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
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of target people: patients with UC who receive cytapheresis in Kitasato University Kitasato Institute Hospital between 22th Aug. 2018 and 31th Mar. 2020.
Management information
Registered date
| 2018 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
