UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001667 |
|---|---|
| Receipt number | R000002017 |
| Scientific Title | Genetic diagnosis of factor V deficiency |
| Date of disclosure of the study information | 2009/02/01 |
| Last modified on | 2012/07/30 11:09:34 |
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Basic information
Public title
Genetic diagnosis of factor V deficiency
Acronym
Factor V gene
Scientific Title
Genetic diagnosis of factor V deficiency
Scientific Title:Acronym
Factor V gene
Region
| Japan |
Condition
Condition
Factor V deficiency
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identify genetic abnormalities of the factor V gene in the patients with factor V deficiency
Basic objectives2
Others
Basic objectives -Others
Predict the amino acid sequences based on the identified genetic variants
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identify genetic variants different from the normal sequences of the factor V gene
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
Patients who are diagnosed as factor V deficiency by general examinations
Key exclusion criteria
not particular
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Izuhara |
Organization
Saga Medical School
Division name
Division of Medical Chemistry, Department of Biomolecular Sciences
Zip code
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Setsuko Sunami |
Organization
Saga Medical School
Division name
Department of Service for Patients
Zip code
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-3137
Homepage URL
sunamis@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Saga Medical School Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 01 | 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
We analyzed 5 patients and 2 families during the past three and half years.
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
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 31 | Day |
Other
Other related information
All of the identified variants were novel missense mutants.
Management information
Registered date
| 2009 | Year | 01 | Month | 29 | Day |
Last modified on
| 2012 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002017
| 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 |
