UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016182 |
|---|---|
| Receipt number | R000018785 |
| Scientific Title | Complehensive immune complexome analysis of serum and biopsies and its application for immune complex antigens in digestive diseases related to the dyscontrol of immune system |
| Date of disclosure of the study information | 2015/01/12 |
| Last modified on | 2015/01/12 10:41:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Complehensive immune complexome analysis of serum and biopsies and its application for immune complex antigens in digestive diseases related to the dyscontrol of immune system
Acronym
Immune complexome analysis in immune-related digestive diseases
Scientific Title
Complehensive immune complexome analysis of serum and biopsies and its application for immune complex antigens in digestive diseases related to the dyscontrol of immune system
Scientific Title:Acronym
Immune complexome analysis in immune-related digestive diseases
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease, Primary biliary cirrhosis, autoimmune hepatitis,autoimmune pancreatitis, rejection after liver transplantation, achalasia, Behcet's disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To indetify specific immune complex antigens in digestive disesses related to the dyscontrol of immune system and to apply for diagnosis, screening eventually leading to exploration of theraputic targets using immune complexome method
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To indetify disease-specific immune complex antigens in digestive disesses using immune complexome method
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis, Crohn's disease, Primary biliary cirrhosis, autoimmne hepatitis, autoimmune pancreatitis, rejection after liver transplantation, achalasia, Bechet's disease
Key exclusion criteria
taking immume regulatory drugs
severe concomitant diseases
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
hajimei2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
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
Address
Tel
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
| 2015 | Year | 01 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To identify autoimmune antigens in digestive diseases related to the dyscontrol of immune system using serum and biopsies obtained by endoscopy and compare with clinical data such as leukocyte counts, CRP, symptoms and signs, each disease activity and severity as multi-institutional joint research
Management information
Registered date
| 2015 | Year | 01 | Month | 12 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018785
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
