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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037109
Receipt No. R000041682
Scientific Title Genetic analysis of multiple endocrine neoplasia type 1
Date of disclosure of the study information 2019/06/19
Last modified on 2019/06/19

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Basic information
Public title Genetic analysis of multiple endocrine neoplasia type 1
Acronym Genetic analysis of multiple endocrine neoplasia type 1
Scientific Title Genetic analysis of multiple endocrine neoplasia type 1
Scientific Title:Acronym Genetic analysis of multiple endocrine neoplasia type 1
Region
Japan

Condition
Condition multiple endocrine neoplasia type 1
Classification by specialty
Endocrine surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Genetic analysis of multiple endocrine neoplasia type 1
Basic objectives2 Others
Basic objectives -Others Genetic analysis of multiple endocrine neoplasia type 1
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Genetic analysis of multiple endocrine neoplasia type 1
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 1) Being a patient (proband) with suspected or multiple endocrine neoplasia type 1 who is undergoing medical treatment at our hospital.
2) The person wants genetic analysis of multiple endocrine neoplasia type 1 (hereinafter, "the relevant genetic analysis"). However, if the subject is under 20 years of age or if it is not possible to make a decision by yourself, explain to the person under the presence of a representative and conduct genetic analysis after sufficiently respecting the person's intention. The signature on the consent form in this case shall be obtained from the representative. The agent is an optional guardian, a custodian, and the person who has a guardian. When there is not, we choose among people concerned from among spouse of adult donor, adult child, parents, adult brothers and sisters or grandchildren, grandparents, close relatives of those living or their close relatives Will be asked to
3) Having received as much explanation as possible from the person in charge of research or co-worker about the purpose, method and significance of the gene analysis, and the method of notifying the result of gene analysis, and agreeing on that.
Key exclusion criteria Patients who do not get consent for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Murao
Organization Kagawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 761-0793
Address Miki-cho, Kita-gun
TEL +81878912230
Email labmed@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Kensaku
Middle name
Last name Fukunaga
Organization Kagawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 761-0793
Address Miki-cho, Kita-gun
TEL +81878912230
Homepage URL
Email labmed@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University Hospital
Institute
Department

Funding Source
Organization Kagawa University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagawa University of Medicine Ethics Committee
Address Miki-cho, Kita-gun
Tel +81878912230
Email chiken@med.kagawa-u.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
2019 Year 06 Month 19 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 20 Day
Date of IRB
2015 Year 01 Month 20 Day
Anticipated trial start date
2015 Year 01 Month 20 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 Genetic analysis of multiple endocrine neoplasia type 1

Management information
Registered date
2019 Year 06 Month 19 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041682

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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