UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Tyrosine Kinase Inhibitor on Thyroid Function in Patients with Chronic Myeloid Leukemia
Acronym	The Effect of Tyrosine Kinase Inhibitor on Thyroid Function in Patients with Chronic Myeloid Leukemia
Scientific Title	The Effect of Tyrosine Kinase Inhibitor on Thyroid Function in Patients with Chronic Myeloid Leukemia
Scientific Title:Acronym	The Effect of Tyrosine Kinase Inhibitor on Thyroid Function in Patients with Chronic Myeloid Leukemia
Region	Japan

Condition
Condition	Chronic Myeloid Leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of tyrosine kinase inhibitor on thyroid function in CML patients
Basic objectives2	Others
Basic objectives -Others	Thyroid function in CML patients will be assessed. In addition, the followings will be investigated: the prevalence of thyroid dysfunction and its relationship with background information (age, sex, etc.) and other factors such as the kind of tyrosine kinase inhibitor the patient takes.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	thyroid function (FT3, FT4, TSH)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-patients who are currently taking or have taken tyrosine kinase inhibitor before -patients with CML in chronic phase -patients with good compliance
Key exclusion criteria	-patients who underwent allogenic hematopoietic stem cell transplantation -patients who do not sign a written consent
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichiro Okamoto
Organization	Keio University School of Medicine
Division name	Department of Hematology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3785
Email	okamoto@a7.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Keiichi Tozawa
Organization	Keio University School of Medicine
Division name	Department of Hematology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3785
Homepage URL
Email	fujimikt@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 12 Month 03 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	Terminated
Date of protocol fixation	2014 Year 09 Month 01 Day
Date of IRB	2014 Year 11 Month 17 Day
Anticipated trial start date	2014 Year 12 Month 03 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	the study was terminated

Management information
Registered date	2014 Year 12 Month 02 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018415