UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045859 |
|---|---|
| Receipt number | R000052055 |
| Scientific Title | A prospective study of treatment response of patients with myelofibrosis and PNH type blood cells |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2025/10/29 13:38:06 |
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Basic information
Public title
A prospective study of treatment response of patients with myelofibrosis and PNH type blood cells
Acronym
A prospective study of treatment response of patients with myelofibrosis and PNH type blood cells
Scientific Title
A prospective study of treatment response of patients with myelofibrosis and PNH type blood cells
Scientific Title:Acronym
A prospective study of treatment response of patients with myelofibrosis and PNH type blood cells
Region
| Japan |
Condition
Condition
myelofibrosis
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess PNH-type cells in myelofibrosis(MF) patients.
Investigate the difference between positive and negative patients.
Basic objectives2
Others
Basic objectives -Others
Prospective observation study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify the MF patients with PNH-type cells
Key secondary outcomes
Assessment of demographic characteristics, clinical signs and symptoms, blood test, urine test, bone marrow test and therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
blood test to detect PNH-type cells
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
Myelofibrosis
patient over 20 years old
Key exclusion criteria
Not appropriate to this study judged by investigator or related
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Juntendo University Hospital
Division name
Department of Hematology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tsutsui@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Juntendo University Hospital
Division name
Department of Hematology
Zip code
113-8421
Address
3-1-3Hongou Bunkyoku
TEL
03-3813-3111
Homepage URL
https://www.gcprec.juntendo.ac.jp/kenkyu/6/
tsutsui@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Miyuki Tsutsui
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongou Bunkyoku
Tel
03-3813-3111
tsutsui@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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
There are few patient who was PNH
Publication of results
Unpublished
Result
URL related to results and publications
There were few patients who was positive for PNH
Number of participants that the trial has enrolled
29
Results
29 patients were enrolled, and 5 patients were positive for PNH blood cells. One patient's anemia worsened, with increased reticulocytes and bilirubin levels, resulting in frequent transfusions. He also had lytic anemia, and PNH blood cell counts were significantly elevated. This is considered a case of myelofibrosis complicated with PNH.
Results date posted
| 2024 | Year | 10 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We analyzed the clinical course of myelofibrosis patient who was positive or negative for PNH.
Date of the first journal publication of results
Baseline Characteristics
PMF:primary myelofibrosis
secondary myelofibrosis
Participant flow
We collected the patient who come to Juntendo Hospital.
Adverse events
There were no adverse events.
Outcome measures
The positive or negative for PNH
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
I collected the data.
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052055
