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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004032
Receipt No. R000004848
Scientific Title A prospective cohort study for prognostic value of serum soluble LR11 in patients with acute leukemia and malignant lymphoma (LR11-study)
Date of disclosure of the study information 2010/09/01
Last modified on 2015/08/12

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Basic information
Public title A prospective cohort study for prognostic value of serum soluble LR11 in patients with acute leukemia and malignant lymphoma (LR11-study)
Acronym LR11-study in acute leukemia and malignant lymphoma
Scientific Title A prospective cohort study for prognostic value of serum soluble LR11 in patients with acute leukemia and malignant lymphoma (LR11-study)
Scientific Title:Acronym LR11-study in acute leukemia and malignant lymphoma
Region
Japan Europe

Condition
Condition Patients with newly diagnosed, previously untreated acute leukemia and malignant lymphoma.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The establishment of serum soluble LR11 as a novel biomarker for acute leukemia and malignant lymphoma.
Basic objectives2 Others
Basic objectives -Others Prospective, observational study
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The association of serum soluble LR11 level at diagnosis and complete response rate.
Key secondary outcomes The association of serum soluble LR11 level and recurrence rate, overall survival rate, and disease free survival rate.
The association of serum soluble LR11 levels and previously known predictive markers.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with written consent of the study.
Key exclusion criteria Patients who could not obtain written consent.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Nakaseko
Organization Department of Clinical Cell Biology,
Chiba University Graduate School of Medicine
Division name Division of Hematology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 043-225-6502
Email chikako_ohwada@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Ohwada
Organization Department of Clinical Cell Biology,
Division name Division of Hematology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 043-225-6502
Homepage URL
Email chikako_ohwada@faculty.chiba-u.jp

Sponsor
Institute Department of Clinical Cell Biology, Chiba University Graduate School of Medicine,
Department of Hematology, Chiba University Hospital
Institute
Department

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

Other related organizations
Co-sponsor Department of Genome Research and Clinical Application, Chiba University, Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1027
Org. issuing International ID_1 Chiba University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2010 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
2015 Year 11 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 30 Day
Date analysis concluded

Other
Other related information Soluble LR11(sLR11) is known to be a biomarker of arterial stenosis, and recently reported to be expressed from human hematopoietic precursors cells. We have recently found that serum sLR11 levels at diagnosis significantly affect CR rate and OS in AML. The aim of this study is to investigate whether serum sLR11 level at diagnosis reflects complete remission rate in acute leukemia patients.

Management information
Registered date
2010 Year 08 Month 11 Day
Last modified on
2015 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004848

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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