UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002729 |
|---|---|
| Receipt number | R000003318 |
| Scientific Title | Detection of markers for immune pathophysiology and analysis of their prognostic value in patients with chronic thrombocytopenia without an increase in the number of bone marrow megakaryocytes: a prospective observation study. |
| Date of disclosure of the study information | 2009/11/16 |
| Last modified on | 2010/02/16 15:57:12 |
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Basic information
Public title
Detection of markers for immune pathophysiology and analysis of their
prognostic value in patients with chronic thrombocytopenia without an increase in the number of bone marrow megakaryocytes: a prospective observation study.
Acronym
Detection of markers for immune pathophysiology and analysis of their
prognostic value in patients with chronic thrombocytopenia without an increase in the number of bone marrow megakaryocytes.
Scientific Title
Detection of markers for immune pathophysiology and analysis of their
prognostic value in patients with chronic thrombocytopenia without an increase in the number of bone marrow megakaryocytes: a prospective observation study.
Scientific Title:Acronym
Detection of markers for immune pathophysiology and analysis of their
prognostic value in patients with chronic thrombocytopenia without an increase in the number of bone marrow megakaryocytes.
Region
| Japan |
Condition
Condition
Pancytopenia, thrombocytopenia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sometimes experience the patients, who show low platelets count but not reach a diagnosis as Idiopathic Thrombocytopenic Purpura (ITP) because of no increment of immature platelets fraction (IPF) in peripheral blood (PB) and megakaryocyte in bone marrow (BM).
Meanwhile, aplastic anemia (AA) is typified by pancytopenia, but some patients decrease in platelets prior to pancytopenia during the course.
Thus, we conduct an prospective study to investigate the frequency and the clinical course of the patients in 'thrombocytopenia with decreased megakaryocytes in BM (TDM)', frequency of PNH+ patients in TDM population, and revealing the response of TDM patients for IST.
Basic objectives2
Others
Basic objectives -Others
Observation study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival of the 'TDM' patients, maintaining the number of platelets greater than 5.0x10e4/mcl.
Key secondary outcomes
1) Changes of the severity of the diseases graded by the clinical stratification for aplastic anemia.
2) Frequency of patients, positive for PNH-type cells.
3) The choice of treatment selected by attending physician.
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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No increment of the number of bone marrow megakaryocytes and peripheral blood examination meets the condition as follows; WBC >= 3000 /mcl
Hb >= 10 g/dl
Platelets < 10 x10e4/mcl
Key exclusion criteria
1) Patients treated by immunosuppressive therapy.
2) Patients with a history of hematologic malignancy.
3) Patients with malignancies requiring treatment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Nakao |
Organization
Kanazawa University Graduate School of Medical Science.
Division name
Cellular Transplantation Biology
Zip code
Address
13-1, Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ishiyama |
Organization
Kanazawa University Graduate School of Medical Science.
Division name
Cellular Transplantation Biology
Zip code
Address
13-1, Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
81-76-265-2274
Homepage URL
ishiyamak@med3.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science.
Institute
Department
Personal name
Funding Source
Organization
Research Committee for the Idiopathic Hematopoietic Disorders, Ministry of Health, Labor, and Welfare, Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
796
Org. issuing International ID_1
Medical Ethics Committee of Kanazawa University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 16 | 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
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective observation study.
Register the patients who meet registration criteria, and follow their clinical course for 5 years.
Management information
Registered date
| 2009 | Year | 11 | Month | 09 | Day |
Last modified on
| 2010 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003318
