UMIN-CTR Clinical Trial

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
Email	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
Email	to-sakurai@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

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
Email	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	2022 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	2022 Year 06 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052729

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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