UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of LRG as a disease monitoring tool in inflammatory bowel disease
Acronym	The usefulness of LRG as a disease monitoring tool in IBD
Scientific Title	The usefulness of LRG as a disease monitoring tool in inflammatory bowel disease
Scientific Title:Acronym	The usefulness of LRG as a disease monitoring tool in IBD
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of LRG as a biomarker in IBD by evaluating the correlation between disease activity, endoscopic findings, MR enterography, and intestinal echo.
Basic objectives2	Others
Basic objectives -Others	The predictive value of LRG
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic accuracy of LRG
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients fulfilling all of the following criteria were subjected to the survey. 1. UC and CD patients who matched the diagnosis of specific disease investigation committee of Japanese ministry of health, labor and welfare and are patients in Kitasato University Kitasato Institute Hospital. 2. Patients of either gender 3. Patients who understood the purpose of experiment and signed a consent form.
Key exclusion criteria	1. When the patient does not agree to the experiment. 2. When the doctor determines that the survey is not medically or ethically adequate to the patient.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Sagami
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code	108-8642
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL	03-3444-6161
Email	jaken1013@live.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Sagami
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code	108-8642
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL	03-3444-6161
Homepage URL
Email	jaken1013@live.jp

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization	Kitasato University Kitasato Institute Hospital
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	Kitasato University Kitasato Institute Hospital Research Department Research Ethics Committee Secretariat
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
Tel	03-3444-6161
Email	kenkyu@insti.kitasato-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	2019 Year 06 Month 10 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	2019 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date	2019 Year 06 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Primary outcomes:The diagnostic accuracy of LRG

Management information
Registered date	2019 Year 06 Month 03 Day
Last modified on	2022 Year 12 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042097