UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016017 |
|---|---|
| Receipt number | R000018620 |
| Scientific Title | Magnifying endoscopic assessment for mucosal healing by leukocytoapheresis in ulcerative colitis patients |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2021/01/15 16:45:17 |
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Basic information
Public title
Magnifying endoscopic assessment for mucosal healing by leukocytoapheresis in ulcerative colitis patients
Acronym
Magnifying endoscopy, leukocytoapheresis and ulcerative colitis
Scientific Title
Magnifying endoscopic assessment for mucosal healing by leukocytoapheresis in ulcerative colitis patients
Scientific Title:Acronym
Magnifying endoscopy, leukocytoapheresis and ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess relationship between magifying endoscopic findings and prognosis of ulcerative colitis treated by LCAP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate clinical course of ulcerative colitis with magnifying endoscopic findings
change of mucosal healing before and after LCAP
Key secondary outcomes
remission period, endoscopic findings, and severity in ulcerative colitis
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis patients treated by LCAP in whom informed consent was obtained to enroll in this study
Key exclusion criteria
severe concomitant diseases such as liver, kidney and heart diseases
prengnant or lactating cases
patients prescribed with ACE inhibitors
unsuitable patients judged by responsible persons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
8528501
Address
1-7-1, Skamoto, Nagasaki
TEL
095-819-7336
hajimei2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
8528501
Address
1-7-1 Nagasaki
TEL
095-819-7336
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology, Nagasaki University 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
Nagasaki university hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197481
kmatsu@nagasaki-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
| 2015 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Number of participants that the trial has enrolled
0
Results
none
Results date posted
| 2021 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients' background: age, sex, diagnosis
disease information: diagnosis, operation, treatment details
labratory data: leukocyte counts and fraction, erythrocyte counts, Hb, platelet counts, CRP
image findings: endoscopic and magnifying endoscopic findings
disease activity index score
Management information
Registered date
| 2014 | Year | 12 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018620
