![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016808 |
Receipt No. | R000019507 |
Scientific Title | The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. |
Date of disclosure of the study information | 2015/03/16 |
Last modified on | 2016/04/02 |
Basic information | ||
Public title | The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. | |
Acronym | The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. | |
Scientific Title | The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. | |
Scientific Title:Acronym | The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. | |
Region |
|
Condition | |||||
Condition | Graves' disease, Hashimoto's thyroiditis, Thyroid nodules, subacute thyroiditis | ||||
Classification by specialty |
|
||||
Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To reveal the significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease. |
Basic objectives2 | Others |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | thyroid function test |
Key secondary outcomes | anti-thyroid antibodies, TRAb, TSAb, ultrasonography |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients with thyroid disease who had visited Wakayama Medical University. | |||
Key exclusion criteria | Patients who were pregnant or who had cancer, inflammatory disease, or thyroid nodules larger than 10 mm in diameter were excluded | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Wakayama Medical University | ||||||
Division name | The 1st Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 811-1 Kimiidera, Wakayama, 641-8509, Japan | ||||||
TEL | 073-441-0625 | ||||||
akamizu@wakayama-med.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Wakayama Medical University | ||||||
Division name | The 1st Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 811-1 Kimiidera, Wakayama, 641-8509, Japan | ||||||
TEL | 073-447-2300 | ||||||
Homepage URL | |||||||
kt10948@wakayama-med.ac.jp |
Sponsor | |
Institute | Wakayama Medical University |
Institute | |
Department |
Funding Source | |
Organization | The Ministry of Health Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
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 |
|
Related information | |
URL releasing protocol | http://www.ncbi.nlm.nih.gov/pubmed/24256421 |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/24256421 |
Number of participants that the trial has enrolled | |
Results | The association with IgG4-related disease was implied in some cases with Graves' disease, Hashimoto's thyroiditis and Riedel thyroiditis. |
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information | Distribution of serum IgG4 levels in patients with thyroid disease. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019507 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |