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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003652
Receipt No. R000004422
Scientific Title Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma
Date of disclosure of the study information 2010/06/01
Last modified on 2017/05/27

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Basic information
Public title Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma
Acronym HCV infection and malignant lymphoma
Scientific Title Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma
Scientific Title:Acronym HCV infection and malignant lymphoma
Region
Japan

Condition
Condition hematopoietic malignancy
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that HCV infection is associated with increased risk for malignant lymphoma in Japan.
Basic objectives2 Others
Basic objectives -Others epidemiologic study
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The difference of the ratio of HCV infected population between malignant lymphoma and other hematopoietic malignancies.
Key secondary outcomes The difference of HCV genotype between malignant lymphoma and other hematopoietic malignancies.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All cases who are newly diagnosed as malignant lymphomam, acute leukemia, plasma cell dyscrasia, myeloproliferative disorders, and myelodysplastic syndrome from July 2009.
Key exclusion criteria not specified
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Nagai
Organization National Hospital Organization Nagoya Medical Center
Division name Clinical Research Center
Zip code
Address 4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL 052-951-1111
Email nagaih@nnh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Nagai
Organization National Hospital Organization Nagoya Medical Center
Division name Clinical Research Center
Zip code
Address 4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL 052-951-1111
Homepage URL
Email nagaih@nnh.hosp.go.jp

Sponsor
Institute Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 06 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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study.
Serial enrollment of newly diagnosed hematopoietic malignancies at registered sites from July 2010.

Management information
Registered date
2010 Year 05 Month 21 Day
Last modified on
2017 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004422

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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