UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003446 |
|---|---|
| Receipt number | R000004169 |
| Scientific Title | Genetic and molecular-biological study of hereditary coagulopathy |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2015/05/07 21:24:16 |
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Basic information
Public title
Genetic and molecular-biological study of hereditary coagulopathy
Acronym
Study of hereditary coagulopathy
Scientific Title
Genetic and molecular-biological study of hereditary coagulopathy
Scientific Title:Acronym
Study of hereditary coagulopathy
Region
| Japan |
Condition
Condition
hereditary coagulopathy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify genetic and molecular biological abnormality in cases with hereditary coagulopathy
Basic objectives2
Others
Basic objectives -Others
Analysis of genetic disorder
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Identification of genetic abnormality and molecular abnormality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patinents who are suspected to suffer from hereditary coagulopathy.
Key exclusion criteria
Patients who do not agree with genetic analysis.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shimpei Kasagi |
Organization
Kobe University Hospital
Division name
Department of clinical laboratory
Zip code
Address
7-5-2, kusunoki-cho, chuo-ku,kobe,hyogo,japan
TEL
078-382-5111
kobe470@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Kawano |
Organization
Kobe University Hospital
Division name
Department of clinical laboratory
Zip code
Address
7-5-2, kusunoki-cho, chuo-ku,kobe,hyogo,japan
TEL
078-382-5111
Homepage URL
http://www.hosp.kobe-u.ac.jp/index.html
sjkawano@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
japan
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
神戸大学医学部付属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | 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
Fifty cases were investigated for AT deficiency and PS deficiency.
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Fifty cases were investigated for AT deficiency and PS deficiency.
Management information
Registered date
| 2010 | Year | 04 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004169
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
