UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019227 |
|---|---|
| Receipt number | R000022206 |
| Scientific Title | Observation of GPI-anchored protein-deficient (PNH-Type) cells In Japanese patients with bone MArrow failure syndrome and in those suspected of having PNH |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2019/07/04 10:16:22 |
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Basic information
Public title
Observation of GPI-anchored protein-deficient (PNH-Type) cells In Japanese patients with bone MArrow failure syndrome and in those suspected of having PNH
Acronym
Observation of GPI-anchored protein-deficient (PNH-Type) cells In Japanese patients with bone MArrow failure syndrome and in those suspected of having PNH
Scientific Title
Observation of GPI-anchored protein-deficient (PNH-Type) cells In Japanese patients with bone MArrow failure syndrome and in those suspected of having PNH
Scientific Title:Acronym
Observation of GPI-anchored protein-deficient (PNH-Type) cells In Japanese patients with bone MArrow failure syndrome and in those suspected of having PNH
Region
| Japan |
Condition
Condition
BMF syndrome (AA, MDS, PNH)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence of patients bearing increased PNH-type granulocytes and erythrocytes in patients with BMF syndrome and in those suspected of having PNH, their peripheral blood samples are examined using high precision flow cytometry method.
Basic objectives2
Others
Basic objectives -Others
Observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients showing PNH-type granulocytes and erythrocytes greater than or equal to 1% at the first FCM analysis
Key secondary outcomes
1.Proportion of patients showing PNH-type granulocytes greater than or equal to 0.003% and erythrocytes greater than or equal to 0.005% identified at the first FCM analysis
2.Changes in percentage of PNH-type cells in the patients who were found to be positive at the first FCM analysis (granulocytes greater than or equal to 0.003% and erythrocytes greater than or equal to 0.005%)
3.Relationship between response to IST made after the PNH-type cell analysis and increase or decrease of PNH-type cells
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.BMF syndrome (AA, MDS, PNH)
2.Suspected of having PNH
3.Patients aged over 16 years and signed a written informed consents by themselves or legal guardians
Key exclusion criteria
1.Patients with malignancies requiring
2.Patients considered inappropriate to participate in the study
3.Patients who has been registered with this study
4.Patients who have used Eculizumab within at the informed consents
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Nakao |
Organization
Graduate school of Medical Sciences, Kanazawa University
Division name
Hematology/Respiratory medicine
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa-shi, Ishikawa
TEL
076-265-2274
snakao8205@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Kimura |
Organization
Japan PNH Study Group
Division name
Research Support Office
Zip code
103-0025
Address
2-17-4 Nihonbashi Kayabacho, Chuo-ku, Tokyo
TEL
03-6810-9713
Homepage URL
tkimura@jpsg.jp
Sponsor or person
Institute
Japan PNH Study Group
Institute
Department
Personal name
Funding Source
Organization
Alexion Pharma Japan
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
Independent Ethics Committee
Address
13-1 Takaramachi, Kanazawa-shi, Ishikawa
Tel
0776-265-2103
t-isomu@adm.kanazawa-u.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
| 2015 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2956
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
| 2011 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Multicenter, prospective observation study. 3 year observation period if PNH clones are positive.
Management information
Registered date
| 2015 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022206
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| Registered date | File name |
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