UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002694 |
|---|---|
| Receipt number | R000003263 |
| Scientific Title | Genetic testing for von Hippel-Lindau disease |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2021/05/09 17:39:06 |
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Basic information
Public title
Genetic testing for von Hippel-Lindau disease
Acronym
Genetic testing for von Hippel-Lindau disease
Scientific Title
Genetic testing for von Hippel-Lindau disease
Scientific Title:Acronym
Genetic testing for von Hippel-Lindau disease
Region
| Japan |
Condition
Condition
von Hippel-Lindau (VHL) disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
genetic diagnosis for von Hippel-Lindau (VHL) disease patient
Basic objectives2
Others
Basic objectives -Others
genetic diagnoses of presymptomatic family members and patients suspected VHL disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
germline mutation detection for von Hippel-Lindau disease (VHL) gene
Key secondary outcomes
optimal patient follow-up based on the phenotype/genotype correlation study
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
1. patients clinically diagnosed as VHL disease
2. presymptomatic members of VHL families
3. patients suspected VHL disease
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro YAO |
Organization
Yokohama City University Graduate School of Medicine
Division name
Urology and Molecular Genetics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2679
masayao@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro YAO |
Organization
Yokohama City University Graduate School of Medicine
Division name
Urology and Molecular Genetics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2679
Homepage URL
masayao@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Neurosurgery, Yokohama City University School of Medicine
Name of secondary funder(s)
none
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
横浜市立大学大学院医学研究科(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. characterization of germline mutational patterns in Japanese patients
2. phenotype/genotype correlation analysis in Japanese patients
3. optimal follow-up and treatment protocols for Japanese patients
Management information
Registered date
| 2009 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003263
