UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047092 |
|---|---|
| Receipt number | R000053715 |
| Scientific Title | Analysis of PD-1 and T cells in the pathophysiology of autoimmune thyroid disease and diabetes mellitus |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2023/09/07 09:51:17 |
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Basic information
Public title
Analysis of PD-1 and T cells in the pathophysiology of autoimmune thyroid disease and diabetes mellitus
Acronym
PD-1 and T cells in autoimmune thyroid disease and diabetes
Scientific Title
Analysis of PD-1 and T cells in the pathophysiology of autoimmune thyroid disease and diabetes mellitus
Scientific Title:Acronym
PD-1 and T cells in autoimmune thyroid disease and diabetes
Region
| Japan |
Condition
Condition
autoimmune thyroid disease and diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Immune checkpoint inhibitors have been effective in treating malignant tumors. However, adverse events of endocrine and metabolic diseases such as type 1 diabetes and autoimmune thyroid disease have been reported. These diseases are associated with autoimmune mechanisms. Therefore, it is expected that immune checkpoint inhibitors may affect autoimmunity. In addition, PD-1 and T cell systems are involved in the development of autoimmune thyroid disease and diabetes. PD-1 and T cells markers may also be predictors of these diseases. The purpose of this study is to investigate the markers of PD-1 and T cells in these diseases.
Basic objectives2
Others
Basic objectives -Others
Comparison of PD-1 and T cell markers for each thyroid disease such as Graves' disease and Hashimoto's disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PD-1+CD4+Tcell
Key secondary outcomes
PD-1+CD8+Tcell, CD25+FoxP3+Tcell, CD4+Tcell, CD8+Tcell, CD26+CD4+Tcell, CD26+CD3+Tcell, IP-10, TARC, Th1, Th2, sCD26
free T3, free T4, TSH, TRAb, TPOAb, TgAb, WBC, lymphocytes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over 15 years old
2) Sex unquestioned
3) The patient who gives a written informed
Key exclusion criteria
1) Patients with a history of immune checkpoint inhibitors
2) Patient with intolerance of medical reasons by doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi 321-0293,Japan
TEL
+81282861111
toshie@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi 321-0293,Japan
TEL
+81282861111
Homepage URL
toshie@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880kita-kobayashi,Mibu,Tochigi 321-0293,Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2022 | Year | 03 | Month | 07 | 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
117
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross section study
Management information
Registered date
| 2022 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053715
