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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013389
Receipt No. R000015623
Scientific Title A prospective cohort study for prognostic value of LR11 in patients with malignant lymphoma (LR11-ML-study)
Date of disclosure of the study information 2014/03/11
Last modified on 2020/03/15

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Basic information
Public title A prospective cohort study for prognostic value of LR11 in patients with malignant lymphoma (LR11-ML-study)
Acronym LR11-ML-study
Scientific Title A prospective cohort study for prognostic value of LR11 in patients with malignant lymphoma (LR11-ML-study)
Scientific Title:Acronym LR11-ML-study
Region
Japan

Condition
Condition Malignant Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The establishment of LR11 expression and serum soluble LR11 as a novel biomarker for malignant lymphoma.
Basic objectives2 Others
Basic objectives -Others Prospective, observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The association of tumor LR11 expression and serum soluble LR11 level at diagnosis and complete response rate.
Key secondary outcomes The association of LR11 level and recurrence rate, overall survival rate, disease free survival rate, and other 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 150

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, 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
Homepage URL
Email chikako_ohwada@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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 1536
Org. issuing International ID_1 Department of Medicine, Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 11 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
2013 Year 10 Month 01 Day
Date of IRB
2013 Year 10 Month 01 Day
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to investigate whether tissue LR11 expression and serum sLR11 level at diagnosis reflect complete remission rate in malignant lymphoma patients.

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2020 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015623

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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