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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029164
Receipt No. 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 2017/09/15

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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
Email 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
Email s-izawa@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 09 Month 15 Day
Last modified on
2017 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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