UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047047 |
|---|---|
| Receipt number | R000053601 |
| Scientific Title | Influence of symptoms on quality of life in patients with polycythemia vera in Japan: A questionnaire survey of physicians and patients |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2022/09/27 10:44:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yedahiro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053601
