UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029164 |
|---|---|
| Receipt number | R000031539 |
| Scientific Title | A New Diagnostic Method for Thyroid Carcinoma Associated with Autoantibody against Cancer Specific Antigen |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2023/03/21 14:46:25 |
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Basic information
Public title
A New Diagnostic Method for Thyroid Carcinoma Associated with Autoantibody against Cancer Specific Antigen
Acronym
Autoantibody against Thyroid Carcinoma Specific Antigen
Scientific Title
A New Diagnostic Method for Thyroid Carcinoma Associated with Autoantibody against Cancer Specific Antigen
Scientific Title:Acronym
Autoantibody against Thyroid Carcinoma Specific Antigen
Region
| Japan |
Condition
Condition
Thyroid Carcinoma
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Endocrine surgery |
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate a new diagnostic method associated with autoantibody against thyroid carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the titer of autoantibody against thyroid carcinoma in 6 groups (progressive thyroid carcinoma, nonprogressive thyroid carcinoma, benign thyroid nodule, Graves' disease, chronic thyroiditis, and normal control)
Key secondary outcomes
1) To invastigate the change of titer in the treatment of thyroid carcinoma
2) To investigate the correlations between autoantibodies against thyroid carcinoma and clinical parameters including pathological diagnosis, cytological diagnosis, thyroid function test, thyroid autoantibodies, and imaging study
3) To investigate the safety including nonspecific antigen-antibody interaction
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Progressive thyroid carcinoma
UICC stage >2 thyroid carcinoma including papillary, follicular, and indifferenciated thyroid carcinoma
2. Inprogressive thyroid carcinoma
UICC stage 1 thyroid carcinoma including papillary and follicular thyroid carcinoma
3. Benign thyroid tumor
Disgnosed as benign by ultrasound and fine needle aspiration cytology
4. Graves' disease
Diagnosed by Guideline for the diagnosis of Graves' disease (JTA 2013)
5. Chronic thyroiditis
Diagnosed by Guideline for the diagnosis of Chronic thyroiditis (JTA 2013)
6. Normal control
Those who fulfill these 4 criteria
1) normal thyroid function
2) thyroid autoantibody (TgAb and/or TPOAb) negative
3) no thyroid nodule detected by ultrasound survey
4) no symptoms and signs were obtained and judged healthy by the researchers
Key exclusion criteria
1. Advanced thyroid carcinoma
1) history of malignant tumor in other organs
2) pregnant or suspected of pregnancy
3) others not suitable for entry
2. Inadvanced thyroid carcinoma
1) history of malignant tumor in other organs
2) pregnant or suspected of pregnancy
3) others not suitable for entry
3. Benign thyroid tumor
1) history of malignant tumor in other organs
2) pregnant or suspected of pregnancy
3) others not suitable for entry
4. Graves' disease
1) history of malignant tumor in other organs
2) post thyroidectomy
3) post I-131 ablation
4) pregnant or suspected of pregnancy
5) others not suitable for entry
5. Chronic thyroiditis
1) history of malignant tumor in other organs
2) post thyroidectomy
3) pregnant or suspected of pregnancy
4) others not suitable for entry
6. Normal control
1) history of malignant tumor in other organs
2) pregnant or suspected of pregnancy
3) others not suitable for entry
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Izawa |
Organization
Tottori University Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
Address
36-1 Nishi-cho, Yonago
TEL
0859-38-6512
s-izawa@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Izawa |
Organization
Tottori University Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
Address
36-1 Nishi-cho, Yonago
TEL
0859-38-6517
Homepage URL
s-izawa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
This study is supported by JSPS KAKENHI Grant number 16K21173
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
| 2017 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031539
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