UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004032 |
|---|---|
| Receipt number | 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 | 2022/11/07 12:41:31 |
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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
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
chikako_ohwada@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Clinical Cell Biology, Chiba University Graduate School of Medicine,
Department of Hematology, Chiba University Hospital
Institute
Department
Personal name
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004848
