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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010141
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hokkaido university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011877

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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