UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047361 |
|---|---|
| Receipt number | R000054016 |
| Scientific Title | The prospective study of the correlation between colonoscopic inflammatory score and biomarkers in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/04/01 19:13:05 |
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Basic information
Public title
The prospective study of the correlation between colonoscopic inflammatory score and biomarkers in patients with ulcerative colitis.
Acronym
UC-LCI-biomarker study
Scientific Title
The prospective study of the correlation between colonoscopic inflammatory score and biomarkers in patients with ulcerative colitis.
Scientific Title:Acronym
UC-LCI-biomarker study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of blood and fecal biomarkers which correlate with mucosal inflammation in UC
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood and fecal biomarkers which correlate with mucosal inflammation in UC at 12w and 24w
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
UC patients with 1 or more and 10 or less of Mayo score
Key exclusion criteria
1)Patients of severe infectious diseases
2)Patients with severe heart diseases or renal diseases
3)Patients with severe dehydration or increased coagulation ability
4) Patients with malignancy
5) Patients with stoma
6)Patients with colectomy within 12weeks
7)Patients who is not appropriate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Tsuzuki |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761667
ytsuzuki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Tsuzuki |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761667
Homepage URL
ytsuzuki@saitama-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
0492762143
rinri@saitama-med.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interim analysis will be performed at the entry of 15 or more patients. This study will be continued until 3 years.
Management information
Registered date
| 2022 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054016
