UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049228 |
|---|---|
| Receipt number | R000055934 |
| 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) |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2022/11/13 09:48:26 |
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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
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
hirokit@mtc.biglobe.ne.jp
Sponsor or person
Institute
Sapporo IBD Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055934
| Research Plan | |
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| Registered date | File name |
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