UMIN-CTR Clinical Trial

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
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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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 06 Month 08 Day
Date of IRB	2010 Year 07 Month 02 Day
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	2020 Year 03 Month 31 Day

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	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004848