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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000347
Receipt No. R000000444
Scientific Title Randomized controlled trial to compare CMV antigenemia assay and real-time PCR after unrelated bone marrow transplantation.
Date of disclosure of the study information 2006/03/10
Last modified on 2008/12/09

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Basic information
Public title Randomized controlled trial to compare CMV antigenemia assay and real-time PCR after unrelated bone marrow transplantation.
Acronym Comparison between CMV antigenemia assay and real-time PCR.
Scientific Title Randomized controlled trial to compare CMV antigenemia assay and real-time PCR after unrelated bone marrow transplantation.
Scientific Title:Acronym Comparison between CMV antigenemia assay and real-time PCR.
Region
Japan

Condition
Condition Bone marrow transplant recipients.
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of antigenemia-based preemptive therapy and real-time PCR-based preemptive therapy to prevent CMV disease after unrelated bone marrow transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Incidence of CMV disease within 100 days after transplantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pre-emptive therapy based on antigenemia assay
Interventions/Control_2 pre-emptive therapy based on real-time PCR
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
55 years-old >=
Gender Male and Female
Key inclusion criteria Patients with hematological malignancies
Use of conventional conditioning regimen.
Transplantation from a serologically HLA-matched unrelated donor.
Key exclusion criteria Life expectancy shorter than 3 months
Both donor and recipient CMV negative
Severe organ dysfunction or infection
ECOG PS 2-4
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kanda
Organization University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3815-5411
Homepage URL http://www.h.u-tokyo.ac.jp/mukin/index.htm
Email ycanda-tky@umin.ac.jp

Sponsor
Institute Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 03 Month 10 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 Completed
Date of protocol fixation
2001 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 03 Day
Last modified on
2008 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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