UMIN-CTR Clinical Trial

Basic information
Public title	Influence of symptoms on quality of life in patients with polycythemia vera in Japan: A questionnaire survey of physicians and patients
Acronym	Influence of symptoms on quality of life in patients with polycythemia vera in Japan: A questionnaire survey of physicians and patients
Scientific Title	Influence of symptoms on quality of life in patients with polycythemia vera in Japan: A questionnaire survey of physicians and patients
Scientific Title:Acronym	Influence of symptoms on quality of life in patients with polycythemia vera in Japan: A questionnaire survey of physicians and patients
Region	Japan

Condition
Condition	Polycythemia vera (PV)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	- To investigate the types and frequency of symptoms in PV patients in Japan and the impact of these symptoms on the quality of life, and to examine the differences in the perception of these symptoms between physicians and patients - To clarify the influence of PV symptoms on the employment status of patients
Basic objectives2	Others
Basic objectives -Others	Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between symptoms affecting employment status and the quality of life in PV patients
Key secondary outcomes	Correlation of survey items between PV patients and physicians

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Research subjects (Physician) 1) A physician who treats at least one PV patient Research subjects (Patients) 1) Patients aged 20 years or older 2) Patients diagnosed with PV
Key exclusion criteria	Not applicable
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Edahiro
Organization	Juntendo University school of Medicine
Division name	Department of Advanced Hematology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL	03-3813-3111
Email	yedahiro@juntendo.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Edahiro
Organization	Juntendo University School of Medicine
Division name	Department of Advanced Hematology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL	03-3813-3111
Homepage URL
Email	yedahiro@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	PharmaEssentia Japan KK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of Juntendo University School of Medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
Tel	03-3814-5672
Email	hongo-rinri@juntendo.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	2022 Year 03 Month 04 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	428
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	Completed
Date of protocol fixation	2021 Year 12 Month 10 Day
Date of IRB	2022 Year 02 Month 18 Day
Anticipated trial start date	2022 Year 03 Month 22 Day
Last follow-up date	2022 Year 07 Month 15 Day
Date of closure to data entry	2022 Year 07 Month 22 Day
Date trial data considered complete	2022 Year 08 Month 09 Day
Date analysis concluded	2022 Year 09 Month 02 Day

Other
Other related information	This study will collect information by questionnaires to physicians and PV patients. The information collected is the information shown in the endpoints.

Management information
Registered date	2022 Year 03 Month 01 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053601