UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035395 |
|---|---|
| Receipt number | R000040323 |
| Scientific Title | Investigation of germline mutation analysis via novel gene panel in Japan |
| Date of disclosure of the study information | 2018/12/28 |
| Last modified on | 2020/12/28 18:43:43 |
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Basic information
Public title
Investigation of germline mutation analysis via novel gene panel in Japan
Acronym
INSIGNIA study
Scientific Title
Investigation of germline mutation analysis via novel gene panel in Japan
Scientific Title:Acronym
INSIGNIA study
Region
| Japan |
Condition
Condition
Hereditary cancer, Familial hypercholesterolemia
Classification by specialty
| Cardiology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose is to detect genetic varitants of those who are suspicious of hereditary cancer or familial hypercholesterolemia(FH) using the hereditary cancer gene panel and the FH gene panel. The target population is Japanese and data collected through these panels will be analyzed for genetic varitants, allele frequencies, and clinical information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of those with genetic variants, genetic variants, association of genetic variants and family/personal medical history
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
| 1 | years-old | < |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Individuals who are suspicisou of hereditary cancer
-Individuals who are suspicisou of familial hypercholestrolemia
Key exclusion criteria
-those who cannot consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Medical and Dental University
Division name
Department of Medical Genetics
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo, Tokyo, Japan
TEL
03-5803-4085
idenbec@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Takamine |
Organization
Tokyo Medical and Dental University
Division name
Department of Medical Genetics
Zip code
1138519
Address
Bunkyo-ku
TEL
+81358034617
Homepage URL
masa.vasc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Medical Genetics
Institute
Department
Personal name
Funding Source
Organization
Patient pay
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
rec.adm@tmd.ac.jp
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
| 2018 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040323
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