UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004521 |
|---|---|
| Receipt number | R000005355 |
| Scientific Title | Early diagnosis of central nervous system involvement of malignant lymphoma by multiplex PCR method |
| Date of disclosure of the study information | 2010/11/10 |
| Last modified on | 2016/12/26 16:49:13 |
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Basic information
Public title
Early diagnosis of central nervous system involvement of malignant lymphoma by multiplex PCR method
Acronym
Early diagnosis of central nervous system involvement of malignant lymphoma
Scientific Title
Early diagnosis of central nervous system involvement of malignant lymphoma by multiplex PCR method
Scientific Title:Acronym
Early diagnosis of central nervous system involvement of malignant lymphoma
Region
| Japan |
Condition
Condition
Malignant Lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect the immunoglobulin heavy chain (IgH) gene rearrangement by multiplex polymerase chain reaction in cerebrospinal fluid in patients with untreated malignant lymphoma.
Basic objectives2
Others
Basic objectives -Others
Validation of biological characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of IgH gene rearrangement
Key secondary outcomes
effect of therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Central nervous system-targeted therapy in patients with IgH gene rearrangement
Interventions/Control_2
Standard therapy (R-CHOP therapy) in patients without IgH rearrangement
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Untreated patients with malignant lymphoma
Key exclusion criteria
Patients without informed consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Tomita |
Organization
Yokohama City University Graduate School of Medicine
Division name
Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Tomita |
Organization
Yokohama City University Graduate School of Medicine
Division name
Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
cavalier@ch-yamate.dlenet.com
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
横浜市立大学附属病院 (神奈川県)、横浜市立大学附属市民総合医療医療センター (神奈川県)、神奈川県立がんセンター (神奈川県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005355
