UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on thyroid dysfunctions in medullary thyroid carcinoma
Acronym	Thyroid dysfunctions in medullary thyroid carcinoma
Scientific Title	Observational study on thyroid dysfunctions in medullary thyroid carcinoma
Scientific Title:Acronym	Thyroid dysfunctions in medullary thyroid carcinoma
Region	Japan

Condition
Condition	Medullary thyroid carcinoma
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of thyroid dysfunctions on the clinical profiles in medullary thyroid cadrcinoma
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tumor markers on medullary thyroid carcinoma
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as medullary thyroid carcinoma
Key exclusion criteria	Patients who are not diagnosed as medullary thyroid carcinoma
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Takeshima
Organization	Wakayama Medical University
Division name	First Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimi-idera, Wakayama
TEL	0734410625
Email	kt10948@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Takeshima
Organization	Wakayama Medical University
Division name	First Department of Internal Medicine
Zip code	6418509
Address	811-1 Kimi-idera, Wakayama
TEL	0734410625
Homepage URL
Email	kt10948@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Nothing
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	Wakayama Medical University Hospital Ethics Committee
Address	811-1 Kimi-idera, Wakayama
Tel	073-441-0867
Email	wa-rinri@wakayama-med.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	2021 Year 02 Month 02 Day

Related information
URL releasing protocol	Nothing
Publication of results	Unpublished

Result
URL related to results and publications	Nothing
Number of participants that the trial has enrolled	1
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	Terminated
Date of protocol fixation	2019 Year 06 Month 03 Day
Date of IRB	2020 Year 06 Month 03 Day
Anticipated trial start date	2020 Year 06 Month 03 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The relationship between thyroid dysfunction and clinical data such as labo data, pathological features, and images.

Management information
Registered date	2021 Year 02 Month 01 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049317