UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014201 |
|---|---|
| Receipt number | R000016517 |
| Scientific Title | Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2020/12/10 09:50:32 |
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Basic information
Public title
Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Acronym
Biomarker for IBD
Scientific Title
Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Scientific Title:Acronym
Biomarker for IBD
Region
| Japan |
Condition
Condition
Inflammatory bowel diseases(ulcerative colitis, crohn's disease), intestinal Behcet disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oligosaccharide analysis of immunoglobulins and cytokines for the biomarkers for the efficacy of biologics in patients with inflammatory bowel diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The titers of biomarkers(serum oligosaccharides in immunoglobulins and cytokines)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with inflammatory bowel diseases(ulcerative colitis, Crohn's disease), Behcet disease
2)Patients who will use or are using biologics (infliximab and adalimumab)
Key exclusion criteria
1) Patients with mental diseases
2) Patients younger than 16 years old.
3) Patients who are not suitable to attend this study judged by physicians.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3621
hiijima@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
Osaka University
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6879-3621
hiijima@gh.med.osaka-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
| 2014 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ecco-jcc/article/11/1/84/2631824
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ecco-jcc/article/11/1/84/2631824
Number of participants that the trial has enrolled
129
Results
In patients with inflammatory bowel diseases (IBD), alterations of oligosaccharide structures of IgA or IgG can serve as diagnostic biomarkers of IBD. Serum leucine-rich alpha-2 glycoprotein was associated with clinical and endoscopic activity of IBD and can serve as a new biomarker for monitoring disease activity of IBD.
Results date posted
| 2020 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 11 | Month | 13 | Day |
Baseline Characteristics
129 patients with ulcerative coltis
Participant flow
Written informed consent was obtained from out or hospitalized ulcerative colitis patients and serum samples and clinical data were obtained from these patients.
Adverse events
N/A
Outcome measures
Correlation of serum LRG and clinical or endoscopic activity of inflammatory bowel disease.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 13 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 13 | Day |
Other
Other related information
Serum samples from the patients treated with biologics will be analyzed for biomarkers.
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016517
