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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037461
Receipt No. R000042685
Scientific Title Mechanism of carcinogenesis of thyroid cancer in young age
Date of disclosure of the study information 2019/07/24
Last modified on 2019/07/23

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Basic information
Public title Mechanism of carcinogenesis of thyroid cancer in young age
Acronym Mechanism of carcinogenesis of thyroid cancer in young age
Scientific Title Mechanism of carcinogenesis of thyroid cancer in young age
Scientific Title:Acronym Mechanism of carcinogenesis of thyroid cancer in young age
Region
Japan

Condition
Condition Papillary thyroid carcinoma
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to elucidate the mechanism of carcinogenesis of thyroid cancer in young age.
Basic objectives2 Others
Basic objectives -Others The aim of this study was to investigate the frequency of BRAF mutation in both adult and pediatric patients, as well as the relationship between mutation rate and clinicopathological features of PTCs in our institution.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The mutation of BRAF, rearrangements of RET/PTC1, RET/PTC3, ETV6/NTRK3, ETV6NTRK in papillary thyroid carcinomas are analyzed.
Key secondary outcomes Association between mutation/rearrangements and clinicopathologicalfeatures are assessed.

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
13 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The studied cases were selected from patients who underwent thyroid resection and were pathologically diagnosed with PTC.
Key exclusion criteria Tumors with
1. extensive fibrosis
2. calcification
3. hematoma
4. cystic lesions
are excluded from the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shoko
Middle name
Last name Kure
Organization Nippon Medical School
Division name Department of Integrated Diagnostic Pathology
Zip code 113-8602
Address 1-1-5, Sendagi Bunkyoku, Tokyo
TEL 03-3822-2131
Email skure@nms.ac.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Kure
Organization Nippon Medical School
Division name Department of Integrated Diagnostic Pathology
Zip code 113-8602
Address 1-1-5, Sendagi Bunkyoku, Tokyo
TEL 03-3822-2131
Homepage URL
Email skure@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization The Children's Cancer Association of Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Clinical Research
Address 1-1-5, Sendagi Bunkyoku, Tokyo
Tel 03-3822-2131
Email officetokutei@nms.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
2019 Year 07 Month 24 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 40
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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2018 Year 01 Month 26 Day
Anticipated trial start date
2018 Year 01 Month 26 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information On going

Management information
Registered date
2019 Year 07 Month 23 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042685

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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