UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051474 |
|---|---|
| Receipt number | R000058722 |
| Scientific Title | Self-Management of Patients with Ulcerative colitis by Fecal Immunochemical Test at Home |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/06/28 22:50:34 |
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Basic information
Public title
Self-Management of Patients with Ulcerative colitis by Fecal Immunochemical Test at Home
Acronym
Self-Management of UC Patients with Ulcerative colitis using FIT
Scientific Title
Self-Management of Patients with Ulcerative colitis by Fecal Immunochemical Test at Home
Scientific Title:Acronym
Self-Management of UC Patients with Ulcerative colitis using FIT
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of Home Fecal Immunochemical Test as a Self-Management Tool for Patients with Ulcerative Colitis in Remission after Reduced Drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse rate that required a stronger level of treatment than before the drug reduction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Fecal Immunochemical test at home
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis
Patient is in clinical remission, FIT negative (hemoglobin level in stool <50 ng/mL)
Patients are scheduled to reduce the dosage of one drug.
Patients who are able to obtain written consent for participation in this study after receiving a thorough explanation of the study and after fully understanding the study.
Outpatients
Key exclusion criteria
Difficulty in performing the fecal immunochemical test at home.
Patients who are deemed inappropriate as research subjects by the principal investigator and research coordinator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Hiraoka |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
7008558
Address
2-5-1 Shikata-cho, kita-ku, Okayama
TEL
0862357219
sakikoh@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Hiraoka |
Organization
Okayama University
Division name
Department of Gastroenterology
Zip code
7008558
Address
2-5-1Shikata-cho, kita-ku, Okayama
TEL
0862357219
Homepage URL
sakikoh@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
Okayama University Ethics Review Committee
Tel
0862356938
mae6605@adm.okayama-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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration was made prior to application to the Ethics Review Board.
This study will be started after it is approved.
Management information
Registered date
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058722
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
