UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033501 |
|---|---|
| Receipt number | 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 | 2024/01/29 11:52:07 |
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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
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
kurodaakio@tokushima-u.ac.jp
Sponsor or person
Institute
Diabetes Therapeutics and Research Center
Institute of Advanced Medical Sciences,
Tokushima University
Institute
Department
Personal name
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
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
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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 2024.
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038201
