UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020054 |
|---|---|
| Receipt number | R000023162 |
| Scientific Title | Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Speciemens obtained from autopsy and surgery)- Multicenter Study - |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2019/06/09 21:39:45 |
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Basic information
Public title
Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Speciemens obtained from autopsy and surgery)- Multicenter Study -
Acronym
usefulness of P.acnes antibody in the diagnosis of cardiac sacoidosis (Autopsy and Surgery)
Scientific Title
Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Speciemens obtained from autopsy and surgery)- Multicenter Study -
Scientific Title:Acronym
usefulness of P.acnes antibody in the diagnosis of cardiac sacoidosis (Autopsy and Surgery)
Region
| Japan |
Condition
Condition
Cardiac Sarcoidosis
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of specific P.acnesantibody (PAB antibody) in spiciemens obtained from autopsy and surgical resection i patients with cardiac sarcoidosis (CS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the prevalence of specific P.acnesantibody (PAB antibody) in spiciemens obtained from autopsy and surgical resection i patients with cardiac sarcoidosis (CS)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Specimens are stored after autopsy or surgery in patients.
2.Regarding using specimens, informed consent are obtained from patients
Key exclusion criteria
1. Specimens are not suitable for our research or assessment due to poor storage condition.
2.Patients disagree with using specimens in the present study.
Target sample size
45
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
TEL
011-706-6973
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
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
TEL
011-706-6973
Homepage URL
mike.s@ninus.ocn.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine,
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center
Tokyo Women's Medical University Hospital
General Aoyama hospital
Fujita Health University Hospital
Wakayama Medical University hospital
Hayama Heart Center
Medical Hospital, Tokyo Medical and Dental University
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 | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Retrospective case-control study
Subjects: Between January 2009 and April 2014, study subjects with some heart diseases including cardiac sarcoidosis were hospitalized in our hospital and the specimens obtained from EMB of them could be stored
In this study, we obtained the agreement of patents or patient's family during participation. If it is difficult for various reasons to directly obtain from them, we posted and published the information or disclosure statement on the board in our departments.
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023162
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/06/09 | 承認版.zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
