UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048079 |
|---|---|
| Receipt number | R000052729 |
| Scientific Title | Comparative study of the efficacy of prostaglandin-E major urinary metabolite with other biomarkers for the determination of activity of inflammatory bowel diseases |
| Date of disclosure of the study information | 2022/06/16 |
| Last modified on | 2023/12/19 20:00:57 |
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Basic information
Public title
Comparative study of the efficacy of prostaglandin-E major urinary metabolite with other biomarkers for the determination of activity of inflammatory bowel diseases
Acronym
COMPROMISE study
Scientific Title
Comparative study of the efficacy of prostaglandin-E major urinary metabolite with other biomarkers for the determination of activity of inflammatory bowel diseases
Scientific Title:Acronym
COMPROMISE study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of prostaglandin-E major urinary metabolite (PGE-MUM) with other biomarkers (including leucin rich alfa glycoprotein and fecal calprotectin) for the determination of the activity of inflammatory bowel disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the equality of the accuracy of PGE-MUM for the determination of activity of inflammatory bowel disease with leucin rich alfa glycoprotein and fecal calprotectin.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis or crohn's disease, who scheduled to undergo colonoscopy or small intestinal endoscopy.
Key exclusion criteria
Patients with:
post total colectomy,
post intestinal surgery within 6 months,
using oral purgatives
using nonsteroidal anti-inflammatory drugs,
using medication associated with prostaglandin,
severe renal dysfuntion
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Saruta |
Organization
The Jikei University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
105-8461
Address
3-25-8, Nishi-shinbasshi, Minato-ku
TEL
+81334331111
m.saruta@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sakurai |
Organization
The JIKEI university school of medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, JAPAN
TEL
+81334331111
Homepage URL
to-sakurai@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The JIKEI university school of medicine
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
Tel
+81334331111
to-sakurai@jikei.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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052729
| Research Plan | |
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| 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 |
