UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053299 |
|---|---|
| Receipt number | R000060666 |
| Scientific Title | Determination of cut-off values for serum Leucine-Rich Alpha-2 Glycoprotein in the diagnosis of disease activity of Crohn's disease. |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/02/19 16:26:30 |
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Basic information
Public title
Determination of cut-off values for serum Leucine-Rich Alpha-2 Glycoprotein in the diagnosis of disease activity of Crohn's disease.
Acronym
Determination of cut-off values for Serum LRG in the diagnosis of disease activity of Crohn's disease.
Scientific Title
Determination of cut-off values for serum Leucine-Rich Alpha-2 Glycoprotein in the diagnosis of disease activity of Crohn's disease.
Scientific Title:Acronym
Determination of cut-off values for Serum LRG in the diagnosis of disease activity of Crohn's disease.
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine the optimal cut-off value of the LRG for Crohn's disease activity.
Basic objectives2
Others
Basic objectives -Others
If the diagnostic accuracy of LRG can be demonstrated, it could replace fecal calprotectine (FC) as a triage biomarker in the diagnosis of Crohn's disease activity. This allows for early therapeutic intervention in the relapse of Crohn's disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cut-off value for Serum LRG in the diagnosis of disease activity of Crohn's disease
Key secondary outcomes
Correlation coefficient between LRG and each covariate, and regression coefficients of each covariate.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have Crohn's disease.
Patients who have a history of outpatient visits or hospitalisation at the Nagoya University hospital, collaborating institutions or institutions that only provide existing samples and information.
Patients who have experience of both LRG measurement and endoscopy.
Key exclusion criteria
Nanopia (Sekisi Medical) is not used in the LRG measurement kit.
The interval between LRG measurement and endoscopy is longer than one month.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shigeyuki |
| Middle name | |
| Last name | Matsui |
Organization
Nagoya university graduate school of medicine.
Division name
Department of Biostatistics.
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya, Japan.
TEL
052-744-2487
smatsui@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Muneyori |
| Middle name | |
| Last name | Okita |
Organization
Nagoya university graduate school of medicine.
Division name
Department of Biostatistics.
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya, Japan.
TEL
052-744-2487
Homepage URL
okita.muneyori.e8@s.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
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
Nagoya University bioethics committee
Address
65 Tsurumai, Showa-ku, Nagoya, Japan.
Tel
0527442479
ethics@med.nagoya-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
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00535-025-02223-1
Number of participants that the trial has enrolled
478
Results
The ROC curve of LRG for diagnosing endoscopic remission in SB patients yielded an AUC of 0.72, and a cut-off value of 10.5 had a sensitivity of 80.2% and specificity of 47.2%. Meanwhile, CRP and DC had an AUC of 0.63 and 0.80, respectively. LRG had a significantly higher diagnostic accuracy versus CRP while there was no significant difference between LRG and FC.
Results date posted
| 2025 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
sensitivity/ specificity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 25 | Day |
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060666
