UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A nationwide survey of clinical outcome of patients with primary myelofibrosis in Japan
Title of the study (Brief title)	A nationwide survey of patients with primary myelofibrosis in Japan
Region	Japan

Condition
Condition	Primary myelofibrosis
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A nationwide survey is conducted to elucidate the clinical features, treatments, and prognosis of primary myelofibrosis patients in Japan
Basic objectives2	Others
Basic objectives -Others	Assessment of internationalprognostic models for Japanese patients with primary myelofibrosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival in patients with primary myelofibrosis in Japan
Key secondary outcomes	Assessment of internationalprognostic models for Japanese patients with primary myelofibrosis

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as primary myelofibrosis
Key exclusion criteria	Reject for enrollment in the study by patients or their family members
Target sample size	700

Research contact person
Name of lead principal investigator	Koichi Akashi
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Medicine and Biosystemic Science
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5228
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	Katsuto Takenaka
Organization	Kyushu University Hospital
Division name	Center for Cellular and Molecular Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5230
Homepage URL
Email	takenaka@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	The Idiopathic Disorders of Hematopoietic Organs Research Committee of Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The Idiopathic Disorders of Hematopoietic Organs Research Committee of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2016 Year 05 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Questionnaires are sent annually to about 500 hematology departments. Newly diagnosed PMF patients are enrolled in this study and are followed annually to collect the prognostic information.The number of enrolled patients per year was around 50.

Management information
Registered date	2016 Year 04 Month 17 Day
Last modified on	2016 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025310