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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001667
Receipt No. 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

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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
Email

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
Email sunamis@cc.saga-u.ac.jp

Sponsor
Institute Saga Medical School Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002017

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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