UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002729
Receipt No. 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

* 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 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
Email

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
Email ishiyamak@med3.m.kanazawa-u.ac.jp

Sponsor
Institute Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.