UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030641 |
|---|---|
| Receipt number | R000029123 |
| Scientific Title | The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/05/08 16:54:19 |
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Basic information
Public title
The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis
Acronym
The usefulness of fecal markers for patients with ulcerative colitis
Scientific Title
The usefulness of fecal markers as predictive markers for induction therapy for patients with ulcerative colitis
Scientific Title:Acronym
The usefulness of fecal markers for patients with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the best choice of fecal markers after starting induction therapy, by evaluating the changes in the values of each marker according to the changes in the sympton and endoscopic findings of UC patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate, The change of fecal markers
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who will receive colonoscopy and additional medication
Patients who agree the participation in this study from due to the published information
Patient who can collect feacal material
Key exclusion criteria
Patients with colectomy
Patients with malignant disease
Patients during pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Hiraoka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
sakikoh@cc.okayama-.u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Hiraoka |
Organization
Okayama University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
Homepage URL
sakikoh@cc.okayama-.u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Biochemical Research Laboratory-I, Eiken Chemical Co.,Ltd. and Self-raising
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 shikata-cho
Tel
0862357552
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
| 2018 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subsequent clinical symptoms and fecal marker of patients with additional treatment are examined and the relationship with response to therapy is analyzed.
Management information
Registered date
| 2017 | Year | 12 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029123
