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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035395
Receipt No. 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 2019/04/05

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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 100

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
Email 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
Email masa.vasc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Department of Medical Genetics
Institute
Department

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
Email 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
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040323

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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