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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000017726 |
Receipt No. | R000020531 |
Scientific Title | Resolution of Graves disease pathophysiology by flowcytometrey |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2017/12/19 |
Basic information | ||
Public title | Resolution of Graves disease pathophysiology by flowcytometrey | |
Acronym | Resolution of Graves disease pathophysiology | |
Scientific Title | Resolution of Graves disease pathophysiology by flowcytometrey | |
Scientific Title:Acronym | Resolution of Graves disease pathophysiology | |
Region |
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Condition | ||
Condition | Graves disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Our purpose is to clarify the pathogenesis of Graves' disease. We investigate the changes of cell surface markers, intracellular signal transducers and cell proliferation response of immunocompetent cells before and after the medication. |
Basic objectives2 | Others |
Basic objectives -Others | observational study |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Subset analysis of the abnormalities and changes after treatment of immunocompetent cells (T cell, B cell, dendritic cell, monocyte, macrophage, and natural killer cell) in Graves' disease. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who have not received the treatment for Graves' disease
Age: 20 years of age and older. It does not matter gender. Patients who agree with this study |
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Key exclusion criteria | Patients who refuse this study
Any patients whom the investigators judged to be inappropriate for this study |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Occupational and Environmental Health | ||||||
Division name | First Department of Internal Medicine, School of Medicine | ||||||
Zip code | |||||||
Address | 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu | ||||||
TEL | 093-603-1611 | ||||||
tanaka@med.uoeh-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Occupational and Environmental Health | ||||||
Division name | First Department of Internal Medicine, School of Medicine | ||||||
Zip code | |||||||
Address | 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu | ||||||
TEL | 093-603-1611 | ||||||
Homepage URL | |||||||
torimoto@med.uoeh-u.ac.jp |
Sponsor | |
Institute | University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Prospective study
Subset analysis of the abnormalities and changes after treatment of immunocompetent cells (T cell, B cell, dendritic cell, monocyte, macrophage, and natural killer cell) in Graves' disease. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020531 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |