UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010175 |
|---|---|
| Receipt number | R000011914 |
| Scientific Title | Prospective observational study of the treatment and prognosis in patients with previously untreated indolent B cell lymphoma |
| Date of disclosure of the study information | 2013/03/11 |
| Last modified on | 2016/03/09 15:33:59 |
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Basic information
Public title
Prospective observational study of the treatment and prognosis in patients with previously untreated indolent B cell lymphoma
Acronym
FLSG09
Scientific Title
Prospective observational study of the treatment and prognosis in patients with previously untreated indolent B cell lymphoma
Scientific Title:Acronym
FLSG09
Region
| Japan |
Condition
Condition
Indolent B-cell Non-Hodgkin's lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify characteristics and prognosis in patients with indolent B-cell Non-Hodgkin's Lymphoma.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to clarify characteristics and prognosis in patients with indolent B-cell Non-Hodgkin's Lymphoma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics and prognosis in patients with indolent B-cell Non-Hodgkin's lymphoma.
Key secondary outcomes
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
1)MATURE B-CELL NEOPLASMS
Small lymphocytic lymphoma
Splenic B-cell marginal zone lymphoma
Lymphoplasmacytic lymphoma
Extranodal marginal zone lymphoma of mucosa-associate lymphoid tissue (MALT lymphoma)
Nodal marginal zone lymphoma
Follicular lymphoma
2)Measurable lesions>=1.5cm by CT scan
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Kato |
Organization
Kyushu University Hospital
Division name
Hematology and Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
fbmtg@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kato |
Organization
Fukuoka Lymphoma Study Group
Division name
FLSG-2010
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
Homepage URL
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Lymphoma Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics
Treatment and progress summary
Management information
Registered date
| 2013 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011914
