UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052832 |
|---|---|
| Receipt number | R000060276 |
| Scientific Title | Study on the usefulness of fecal calprotectin by gold colloid agglutination in ulcerative colitis and the relevance of other biomarkers |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/17 23:26:37 |
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Basic information
Public title
Study on the usefulness of fecal calprotectin in ulcerative colitis and the relevance of other biomarkers
Acronym
UC-CAL Study
Scientific Title
Study on the usefulness of fecal calprotectin by gold colloid agglutination in ulcerative colitis and the relevance of other biomarkers
Scientific Title:Acronym
UC-CAL Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine whether there is a correlation between the gold colloid agglutination and FEIA stool calprotectin tests in patients with ulcerative colitis. In addition, the correlation between stool calprotectin tests and clinical scores such as the Mayo score, existing biomarkers such as LRG, fecal occult blood qualitative and quantitative tests, and histopathological findings is analysed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the usefulness of the gold colloid agglutination method in patients with ulcerative colitis by analysing the correlation between the gold colloid agglutination method and the FEIA stool calprotectin test at the time of colonoscopy.
Key secondary outcomes
To assess reagent and instrument performance in order to assess whether the stool calprotectin values obtained in the main evaluation are adequate.
To assess the correlation between stool calprotectin values obtained in the main evaluation and existing biomarkers.
To assess the correlation between existing biomarkers.
To assess the correlation between stool calprotectin levels and existing biomarkers obtained in the main evaluation and clinical scores or histopathological findings, and how they are assessed in combination.
Evaluate the ability of stool calprotectin levels and existing biomarkers obtained in the main evaluation to discriminate between patients with non-ulcerative colitis and patients with ulcerative colitis, or to discriminate between patients with ulcerative colitis and patients with ulcerative colitis in terms of disease activity.
Using the first faecal evacuation during colonoscopy, assess the stability of stool markers in stool and in the stool sample after adjustment.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18-70 years with ulcerative colitis or non-ulcerative colitis and symptomatic conditions scheduled for close examination by colonoscopy.
Key exclusion criteria
Persons who are unable to give their consent.
Persons who cannot understand the explanation.
Persons who are judged to be unable to undergo colonoscopy due to their general condition.
Persons whose prothrombin time is less than 50% or platelet count is less than 50,000/microl in the blood test.
Persons deemed unsuitable by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Mirai |
| Middle name | |
| Last name | Hayashi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
8F, Main Building, Faculty of Medicine, Ehime University, 454 Shizugawa, Toon, Ehime, Japan
TEL
0899605308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | |
| Last name | Hayashi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
8F, Main Building, Faculty of Medicine, Ehime University, 454 Shizugawa, Toon, Ehime, Japan
TEL
0899605308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Mirai Hayashi
Funding Source
Organization
Alfresa Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Address
8F, Main Building, Faculty of Medicine, Ehime University, 454 Shizugawa, Toon, Ehime, Japan
Tel
0899605308
3naika@m.ehime-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
| 2023 | Year | 11 | 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
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case-control study
Method of recruitment of subjects: patients presenting at the institution between 1 October 2023 and 31 March 2026 who met the selection criteria.
Measurements: stool calprotectin, faecal occult blood, faecal transferrin, LRG, CRP, erythrocyte sedimentation rate, white blood cells, Mayo score, etc.
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060276
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