UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010141 |
|---|---|
| Receipt number | R000011877 |
| Scientific Title | Investigation of Sensitivity and Specificity in Pripoinibacterium Acnes Specific Monoclonal Antibodies of Cardiac Sarcoidosis |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2017/03/29 15:33:53 |
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Basic information
Public title
Investigation of Sensitivity and Specificity in Pripoinibacterium Acnes Specific Monoclonal Antibodies of Cardiac Sarcoidosis
Acronym
Investigation of Sensitivity and Specificity in Pripoinibacterium Acnes Specific Monoclonal Antibodies of Cardiac Sarcoidosis
Scientific Title
Investigation of Sensitivity and Specificity in Pripoinibacterium Acnes Specific Monoclonal Antibodies of Cardiac Sarcoidosis
Scientific Title:Acronym
Investigation of Sensitivity and Specificity in Pripoinibacterium Acnes Specific Monoclonal Antibodies of Cardiac Sarcoidosis
Region
| Japan |
Condition
Condition
Cardiac Sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed endmyocardial biopsy of cardiac sarcoidosis and investigated sensitivity and specificity in pripoinibacterium acnes specific monoclonal antibodies(PAB antibody).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of PAB antibody in cardiac sarcoidosis
Key secondary outcomes
We compared sensitivity and specificity of PAB antibady with cardiac sarcoidosis and the other heart disease.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cardiac sarcoidosis group
The patients who diagnosed cardiac sarcoidosis.
Control group
The other heart disease, who didn't diagnosed cardiac sarcoidosis.
Key exclusion criteria
We excluded the patients, we couldn't obtain the consent, we couldn't perform endomyocardial biopsy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-6973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
We prepare publish.
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011877
