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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033501
Receipt No. R000038201
Scientific Title Detection of pancreatic beta cell DNA in the circulation of patients with type 1 diabetes using the dual Amplification Refractory Mutation System PCR
Date of disclosure of the study information 2019/03/31
Last modified on 2019/03/22

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Basic information
Public title Detection of pancreatic beta cell DNA in the circulation of patients with type 1 diabetes using the dual Amplification Refractory Mutation System PCR
Acronym Detection of pancreatic beta cell DNA in the circulation using the dual Amplification Refractory Mutation System PCR
Scientific Title Detection of pancreatic beta cell DNA in the circulation of patients with type 1 diabetes using the dual Amplification Refractory Mutation System PCR
Scientific Title:Acronym Detection of pancreatic beta cell DNA in the circulation using the dual Amplification Refractory Mutation System PCR
Region
Japan

Condition
Condition type 1 diabetes, pancreas transplantation, islet transplantation
Classification by specialty
Endocrinology and Metabolism Hepato-biliary-pancreatic surgery Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a precise method for detecting pancreatic beta cell DNA in the circulation.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To develop a precise method for detecting pancreatic beta cell DNA in the circulation in 370 patients with type 1 diabetes, pancreas or islet transplanted patients.
Key secondary outcomes The comparison between beta cell DNA positive patients and their clinical characteristics.

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 Patients with type 1 diabetes, person with familial history of type 1 diabetes, person who are suspects of type 1 diabetes, pancreas or islet transplanted patients, patients with type 2 diabetes, and healthy volunteer subjects.
Key exclusion criteria Any condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.
Target sample size 370

Research contact person
Name of lead principal investigator
1st name Munehide
Middle name
Last name Matsuhisa
Organization Institute of Advanced Medical Sciences,
Tokushima University
Division name Diabetes Therapeutics and Research Center
Zip code 770-8503
Address Kuramoto cho, Tokushima, Japan 7708503
TEL 088-633-7587
Email matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Kuroda
Organization Institute of Advanced Medical Sciences, Tokushima University
Division name Diabetes Therapeutics and Research Center
Zip code 770-8503
Address Kuramoto cho, Tokushima, Japan 7708503
TEL 088-633-7587
Homepage URL
Email kurodaakio@tokushima-u.ac.jp

Sponsor
Institute Diabetes Therapeutics and Research Center
Institute of Advanced Medical Sciences,
Tokushima University
Institute
Department

Funding Source
Organization Regional Innovation Strategy Support Program, Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Medical Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Address 2-50-1, Kuramoto cho, Tokushima, Japan 7708503
Tel 088-633-9294
Email awachiken@tokushima-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 17492
Org. issuing International ID_1 Osaka University Medical Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 徳島大学病院(徳島県)、大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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
2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients or healthy volunteers who come to Tokushima university hospital and other related hospitals, who are eligible for the criteria from July 2018 until December 2019.

Management information
Registered date
2018 Year 07 Month 24 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038201

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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