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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024288
Receipt No. R000027931
Scientific Title Pilot study of return of genetic results to individual participants of the large cohort study
Date of disclosure of the study information 2016/10/06
Last modified on 2016/10/04

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Basic information
Public title Pilot study of return of genetic results to individual participants of the large cohort study
Acronym Pilot study of return of genetic results to individual participants of the large cohort study
Scientific Title Pilot study of return of genetic results to individual participants of the large cohort study
Scientific Title:Acronym Pilot study of return of genetic results to individual participants of the large cohort study
Region
Japan

Condition
Condition familial hypercholesterolemia
Classification by specialty
Endocrinology and Metabolism Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this exploratory study is to establish the framework and system of return of individual genetic results for research participants in the large biobank-based population cohort. We measure the psychosocial impact of return of the genetic results of familial hypercholesterolemia.
Basic objectives2 Others
Basic objectives -Others Attitudes, psychosocial impacts, distress and experiences of return of the genetic results of familial hypercholesterolemia
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Primary outcome: Psychosocial impacts, distress and experiences of return of genetic results
Measures: K6, POMS2, IES-R, Questionnaire for genetic literacy, Questionnaires and interviews for experiences of return of genetic results
Timeline: Pre, post, after 6 months, 12 months
Key secondary outcomes Secondary outcome:
1) Validation of genetic analysis
2) Attitudes, satisfactions, and effects of Genetic Lecture

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participants of Tohoku Medical Megabank Cohort, with age over 20 years-old, and TC>250 mg/dl, and/or LDL-C>180 mg/dl, and/or a history of treatments of hyperlipidemia are returned the genetic results of familial hypercholesterolemia (LDLR, PCSK9, APOB), after the informed consent of this pilot study.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Participants of Tohoku Medical Megabank Cohort
2) Age over 20 years-old
3) Participants whose genome was analyzed
4) TC>250 mg/dl, and/or LDL-C>180 mg/dl, and/or a history of treatments of hyperlipidemia
Key exclusion criteria Participants who checked : No return of results
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIROSHI KAWAME
Organization Tohoku University Tohoku Medical Megabank Organization
Division name Group of return of genomic results
Zip code
Address 980-8573 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan
TEL 022-274-6017
Email hkawame@megabank.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIROSHI KAWAME
Organization Tohoku University Tohoku Medical Megabank Organization
Division name Group of return of genomic results
Zip code
Address 980-8573 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan
TEL 022-274-5998
Homepage URL
Email hkawame@megabank.tohoku.ac.jp

Sponsor
Institute Tohoku University Tohoku Medical Megabank Organization
Institute
Department

Funding Source
Organization AMED (Japan Agency of Medical Research and Development)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor Iwate Tohoku Medical Megabank Organization
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 東北メディカル・メガバンク機構(宮城県)
地域支援気仙沼センター(宮城県)
地域支援大崎センター(宮城県)
地域支援石巻センター(宮城県)
地域支援多賀城センター(宮城県)
地域支援仙台センター(宮城県)
地域支援岩沼センター(宮城県)
地域支援白石センター(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 06 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027931

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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