UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early diagnosis of central nervous system involvement of malignant lymphoma by multiplex PCR method
Title of the study (Brief title)	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	Naoto Tomita
Organization	Yokohama City University Graduate School of Medicine
Division name	Internal Medicine and Clinical Immunology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email

Public contact
Name of contact person	Naoto Tomita
Organization	Yokohama City University Graduate School of Medicine
Division name	Internal Medicine and Clinical Immunology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	cavalier@ch-yamate.dlenet.com

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 11 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005355