UMIN-CTR Clinical Trial

Basic information
Public title	Serum leucine-rich alpha-2 glycoprotein levels for predicting ultrasonographic findings in intestinal lesion of patients with Crohn's disease in clinical remission (SAPICL study)
Acronym	SAPICL study
Scientific Title	Serum leucine-rich alpha-2 glycoprotein levels for predicting ultrasonographic findings in intestinal lesion of patients with Crohn's disease in clinical remission (SAPICL study)
Scientific Title:Acronym	SAPICL study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the relationship between the severity of intestinal ultrasonographic findings and leucine-rich alpha-2 glycoprotein (LRG) levels for Crohn's disease in clinical remission.
Basic objectives2	Others
Basic objectives -Others	To evaluate the LRG cutoff value for predicting the activity of intestinal ultrasonographic parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Determining the cutoff value of LRG levels for predicting positive bowel wall thickness (BWT), focally or extensively disrupted bowel wall echo patterns, and respective superb micro-vascular imaging(SMI) grades and calculating the sensitivity and specificity.
Key secondary outcomes	Comparison of the median LRG levels for the positive BWT, focally or extensively disrupted bowel wall echo patterns, and respective SMI grades. Proportion of patients with positive BWT, those with focally or extensively disrupted bowel wall echo pattern, and those with respective SMI grades, respectively stratified by cutoff value of LRG levels. Proportion of patients with focally or extensively disrupted bowel wall echo pattern and that with respective SMI grades, respectively stratified by BWT. Evaluating the background factors related to the LRG levels. Determining the LRG cutoff value stratified by the background factors related to LRG levels and calculating the sensitivity and specificity. Etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CD patients of all ages who had evaluated LRG levels and received intestinal ultrasonography on the same day between September 2020 and August 2022.In case that LRG measurement and intestinal ultrasonography were performed multiple times within the applicable period, the first time of the investigation were recruited.
Key exclusion criteria	(1) Patients whose data of Harvey-Bradshaw Index (HBI) could not be evaluated from medical records. (2) Patients whose HBI is 5 or above. (3) Patients who had underwent intestinal resection.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Tanaka
Organization	Sapporo IBD Clinic
Division name	N/A
Zip code	064-0919
Address	Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
TEL	011-213-0397
Email	hirokit@mtc.biglobe.ne.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Tanaka
Organization	Sapporo IBD Clinic
Division name	N/A
Zip code	064-0919
Address	Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
TEL	011-213-0397
Homepage URL
Email	hirokit@mtc.biglobe.ne.jp

Sponsor
Institute	Sapporo IBD Clinic
Institute
Department

Funding Source
Organization	None
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	Sapporo IBD Clinic
Address	Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
Tel	011-213-0397
Email	hirokit@mtc.biglobe.ne.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 10 Month 17 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	Enrolling by invitation
Date of protocol fixation	2022 Year 10 Month 14 Day
Date of IRB	2022 Year 10 Month 18 Day
Anticipated trial start date	2022 Year 10 Month 18 Day
Last follow-up date	2025 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2022 Year 10 Month 16 Day
Last modified on	2022 Year 11 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055934