UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037592 |
|---|---|
| Receipt number | R000042858 |
| Scientific Title | Comprehensive analysis of serum peptides useful for diagnosis of inflammatory bowel diseases |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2023/08/19 11:15:35 |
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Basic information
Public title
Comprehensive analysis of serum peptides as candidate biomarkers for inflammatory bowel diseases
Acronym
Analysis of candidate serum biomarkers for inflammatory bowel diseases
Scientific Title
Comprehensive analysis of serum peptides useful for diagnosis of inflammatory bowel diseases
Scientific Title:Acronym
Analysis of serum peptides useful for diagnosis of IBD
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease, intestinal Bechet's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find serum peptides useful for differential diagnosis of ulcerative colitis, Crohn's disease, and intestinal Bechet's disease. Generation and valiation of discriminant models useful for the above differential diagnosis.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether inflammatory bowel diseases are distinguished from intestinal Behcet's disease by protein spot intensity obtained from 2-dimensional electrophoresis of peripheral blood mononuclear cell-derived proteins
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ion intensity of serum peptides and usefulness of discriminant models for inflammatory bowel diseases generated by the serum peptide ion intensity
Key secondary outcomes
Protein spot intensity obtained from 2-dimensional electrophoresis of peripheral blood mononuclear cell-derived proteins
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed and suspected as ulcerative colitis, Crohn's disease, intestinal Behcet's disease, rheumatoid arthritis, and collagen diseases in St. Marianna University Hospital. Healthy individuals who visited St. Marianna University Hospital and who are staff members of St. Marianna University School of Medicine and St. Marianna University Hospital.
Key exclusion criteria
Patients whose condition is not good, i.e., moderate to severe anemia
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kato |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
81-44-977-8111
masaki0801_3@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kato |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
81-44-977-8111
Homepage URL
masaki0801_3@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University 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
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel
81-44-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3865
Org. issuing International ID_1
St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学(神奈川県)、聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods for Evaluation of Primary Outcome:
Peptides are extracted from sera of the patients and healthy individuals by weak cation exchange, and ion intesity of the peptides are comprehensively measured by mass spectrometry. Discriminant models for inflammatory bowel diseases are generated and validated using the ion intensity by multivariate analysis.
Management information
Registered date
| 2019 | Year | 08 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042858
